ML20214B816
| ML20214B816 | |
| Person / Time | |
|---|---|
| Site: | 07002232 |
| Issue date: | 04/15/1976 |
| From: | Vacca P NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Beth Brown WEST JERSEY HOSP., CAMDEN, NJ |
| Shared Package | |
| ML20214B621 | List: |
| References | |
| NUDOCS 8705200423 | |
| Download: ML20214B816 (3) | |
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APR 1 5 1976 FCMS RLE PCY (70-2232)
West Jersey Hospital ATTN: Barry Brown President Mount Ephrim and Atlantic Avenue
-Camden, New Jersey 08104
, Centlemen 4 This refers March 23, 1976)to yorar application dated February 20,1976 (received for a special nuclear material license to participate in the investigational nuclear powered pacemaker. program utilizing the Cordis Omsti-Stanicor No.184A The implantation of nuclear powered pacemakers in patients is being licensed lished that:only on a limited investigational basis until it can be estab-(1) nuclear pacemakers are safe and reliable; (2) wide-scale use will not subject the public to undue risk; and (3) the benefits to be derived by patients using nuclear powered pacemakers will outweigh the risks, however small, to the public, which might occur through an accident environment. involving a pacemaker bearer or loss of the paceansker to the During the investigational phase of nuclear pacemaker use, licenses are followup physicians. of patients with implanted pacemakers, and not to ,
The physicians designated in an application as responsible i investigators should have substantial experience with paceanskers in the
{ specialties of cardiology and thoracic surgery, and the applicant medical i institution will generally be expected to have an established program j for the implantation and followup of cardiac pacemakers. A study team
_ approach is emphasized.
j 1 should be supported with the additional information listed below:With ref
-} 1.
j List the cardiologist member (s) of your study team and supply the following information on each cardiologist Name, office address, board certification, position with the applicant, and previou experience as given for other members of the study team.
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. i-West Jersey Hospital :
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,The other physietans responsible for and participating in the study as members of your study team should each certify that be is familiar i
.with the Cordia Nuclear ommi-Stanieor No. 184A protocol and understands that the issuance of the license to West Jersey Hospital is conditioned
] upon the following of the protocol.
- 3. Your instructions to telephone operators should imelude the nams and telephone number of several study team members who should be "
l eestaeted.
- 4. In Item 6 of your application, you state that "the physician follows i
j all pacer patients both transtelephonically and by occasional visits
- to his office." From this statement it is unclear how all of the
" ' followup data required on Cordis Form 2 -(page B-5 of the protocol)
- will be obtained. For example, how will it be 'deternised that the i
patient is carrying his ID card and that he is faithfully wearing
' the required bracelet er its equivalent?
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- We will coatisme our review of your application promptly upon receipt of the requested information. Please reference Docket No. 70-2232 in your j reply.
1 Sincerely, i
1 ,.
Fatricia C. Vacca
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Radioisotopes Licensing Branch Division of Fuel Cycle and j Material Safety cer Mr. Norm Baker
) Cordis Corporation j 210 Northeast 18th Street 1
Miami, Florida 33137 l Std. Br. Dist.
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Technical Programs 7f(q, LICENSE Ftt TRAN5MITTAL -
A. REG 10N p
- 1. APPLICATION ATTACHED Applicant /ttcensee: hc%4 Up s v Mce,ddn '
> I Appifcation Dated: 7 R9 I 9(, .
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Control No.: 105924
- License No.: %Mm- 44(,
2 FEE ATTACHED Amount: o, Check No.: 0
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- 3. COMMENTS Signed hRonvhDnTch Date 59 ) FL B. LICENSE FEE MANAGEMENT BRANCH
- 1. Fee Category and Amount: Ar 7e u A __,wov
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- 2. Correct Fee Paid. Application nuy be processed for:
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SE Ic.end.v.ent -
Renewal N .
License ,
Signed i />t elh Date ?f(n [Ph
'l W I FORM 213