ML20009C935
| ML20009C935 | |
| Person / Time | |
|---|---|
| Site: | 07001342 |
| Issue date: | 06/03/1981 |
| From: | Kallas D BIOCONTROL TECHNOLOGY, INC. (FORMERLY CORATOMIC |
| To: | Vacca P NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20009C937 | List: |
| References | |
| 19217, NUDOCS 8107220180 | |
| Download: ML20009C935 (3) | |
Text
'7M- /3M BeMcu tu w c,rator6fErt, N.
P.O. BOX 434 INDIANA, PENNSYLVANI A 15701 FHONE 14121349-1811 TELEX 86-6658 June 3, 1981 cv Mrs. Patricia C. Vacca 03 Radioisotope Licensing Branch Division of Fuel Cycle and 2-d Materials Safety F
-c3 U. S. Nuclear Regulatory Commission g
Washington, D. C.
20555 ca
- har Mrs. Vacca
Coratomic, Inc. is requesting a temporary amendment change to our special nuclear material license, SNM 1319, for the shipment of two C101-P pacemakers, Serial Numbers 1156 and 1157, to Ken Williams at Washington Hospital Center, Ref. SNM-1446.
Mr. Rahmoeller fo the FDA has given verbal approval to implant the above pacemakers under the custom device law with shipments of all other C101-P's being halted until approval from FDA and NRC.
See the enclosed sheet for specifications on Coratomic, Inc. model C101-P vs Cordis Corporation model Omni-Stanicor.
Coratomic's model is more desirable for long-term implant due to the wider range of programmability.
It should also be noted that the C101-P also has a weight and size advantage over other isotopic pacemakers.
It is for humanitarian reasons that we are requesting that the NRC react on the license amendment change.
Enclosed is the amendment fee
-of $464. Doctor Nic.holas P. D. Smyth, M.D. has requested two C101-P pacemakers as custom devices for implant in patients requiring this device.
Please co-ordinate our amendment change with Washington Hospital Center change for all requested information.
Coratomic, Inc. regrets any misunderstanding between the three parties, the FDA, NRC and Coratomic. We were under the impression the NRC and FDA were in agreement on the implants. We hope that.NRC, JDA.and Coratomic, Inc. can wor'c together with more c rity ye ghtE!funuteML f O[d $.
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PDR ADOCK 07001342 1
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Nuclear. Powered Programmable,R-Wave 7,3 perm -
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InNbited (WI) Cardiac Pacer 5
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Specifications (at 37'C and time of manufacture)
Normna:
Range Output current *, mA (as programmed) 8 (High) 7-10
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5 (Med) 4-7 3 5 (Low) 3-5 2.0 (Test) 1.5-3.0 Fixed rate. ppm (as programmed) 60 58 64 65 63-69 70 68-74 80 78-85 90 88-97 100 98-108
.Meawed into a $10-ohm load arx1 sampled 0 2 ms output voltage, V (open circuit).
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- ' tne stan d ine poise tMeawed *4th a rectangat v vopage s:ep Sens.tiv tf Sensitivityt (+ or -), mV 1.5 1.0-2 0 vanes s.gn+ cant;y.tn ene rate at an'.en the inrx1 sig w r:ses and !ne du at.on of the ris ng vcitage Pulse durationt, ms (at 70 ppm).
1.7 1 6-1.8 gy,,',s,,,n,,,, se,,n,,nsi,uct.ons supphed we the r
Refractory *, ms (at 70 ppm)
.311 289-326 P8C"
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8 Caution: Federal (U.S A.) law restncts Size.
56 x 68 x 20 mm th:0 device to sale by or on the order of Specific gravity 1.80 a pnysician.
Radiopaque identif cation letters
. DH (Model 184A)
Pnor to implantation, read the instructfons PJ (Model 184B) supplied with the racer
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t i o Cordis Corporation p r
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!p Miami, Fla 33137, U S A l'~,
Telephone 305-578-2000
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DIMENSIONS & SPECIFICATIONS - C-101-P Programmable Isotopic Weight 61 gm
' Max. Thickness...
1.9 cm Height 5.1 cm Length...........
6.4 cm Specific Gravity.
1.56 gm/cc Longevity......... At 40-45 years, a rate drop of approx. 10% will begin.
The transition to the 10% decrease will take approx. 3 years.
After the 3-years, the rate will remain relatively constant for another 30 years.
Pacing Rate....... Programmable @ 38 to 120 ppm 13 4 Pulse Current..... Programmable @ 4 and 10 ma (leading edge, BOL)
Sensitivity....... Programmable @ 1.5, 2.5, 4.0, 5.0 mv Pulse Width......
1.0 0.1 msec @ BOL (increases to 1.4 msec @ EOL)
Pulse Voltage....
5.4 v, nominal @ 10.6 ma Escape Rate
.......'Same as programmed pacing rate Magnetic Rate..... Same as programmed pacing rate N ise Ra e
< 25 hz (will switch to an asynchronous mode at: the programmed rate when continuous electromagnetic interference is encountered at or above its noise threshold)
Normally used as an R-wave inhibited (VVI) pacemaker.
Asynchronous (V00) pacing can be obtained by placing the SENSITIVITY selector to its FR (Fixed Rate) setting.
Available only in unipolar ~ design (at this time)
Hermitically sealed in a titanium case.
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