ML20211K398
| ML20211K398 | |
| Person / Time | |
|---|---|
| Site: | 07001402 |
| Issue date: | 06/06/1973 |
| From: | George M, Knowlton S ABINGTON MEMORIAL HOSP., ABINGTON, PA |
| To: | Marlaro J US ATOMIC ENERGY COMMISSION (AEC) |
| Shared Package | |
| ML20211K358 | List: |
| References | |
| 3798, NUDOCS 8606270391 | |
| Download: ML20211K398 (3) | |
Text
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June 6, 1973 j
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Chief of Materials Branch a
s Division of Materials Licensing N
Atomic Energy Commission Washington, D.C.
20545 Attention:
James C.
Malaro TM Fe:
Application for License to Implant Medtronic Laurens-Alcatel Model 9000 Isotopic Pulse Generator Gentlemen:
The following information is submitted in application for a license TM to implant the Medtronic Laurens-Alcatel Model 9000:
1.
Applicant:
Abington Memorial Hospital 2.
Physician Responsible for Study:
Name:
Stephen B. Knowlton, Jr.,
M.D.
Office Address:
1245 Highland Avenue, Abington, Pa. 19001 Telephone Number:
(215) TU 7-3990 State Licensed to Practice In:
Pennsylvania Medical School Affiliation:
Temple University Specialty Board Certification:
American Board of Surgery Position with Applicant:
Associate Surgeon Previous experience in the clinical use of Implantable pace-makers by physician:
Total implants:
215 at Ibington Memorial Hospital 2 at U.S.
Naval Hospital, Philadelphia
/ Of total, 4 were myocardial leads.
3.
Other physicians and surgeons participating in study:
None.
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V Chief of Materials Branch Page 2 June 6, 1973 TM 4.
Protocol to be followed:
Medtronic Laurens-Alcatel Model 9000 Isotopic Pulse Generator Protocol dated March 21, 1973.
Modifications to Protocol:
None.
TM aurens-Alcatel Model 9000 requested 5.
Number of Medtronic L
to be implanted annually during study:
six
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6.
Description of physical facilities and equipment at applicant:
l Abington Memorial Hospital has a seven-bed Coronary Care Unit, five-bed Medical Intensive Care Unit, and an eleven-bed I
Surgical Intensive Care Unit, fully staffed and equipped.
The Operating Room Unit consists of ten operating rooms, all of which are capable of being equipped with portable cardiac monitors.
For pacemaker insertions, a two-channel American
/ Optical Cardioscope with constant electrocardiographic and pulse is used for monitoring.
When endocardial electrodes are used, a portable Westinghouse Image Intensifier is used.
7.
Description of Applicant's present pacemaker implantation and follow-up program:
Since 1963, 301 generators have been implanted in 189 patients.
Follow-up has been supervised by any of five Board _ Certified cardiologiats on staff of Abington Memorial Hospital, generally at monthly intervals of 3, 3,
6, 6 months following implant and then monthly until replacement.
Elective replacement in past five years has constituted 90 per cent of all replacements.
The physician responsible for the study represents that he is familiar with Medtronic's Protocol and Technical Manual for the MedtronicTMLaurens-Alcatel Model 9000 and understands that the issuance of a license is conditioned upon the use of this Protocol and is conditioned on the following of the instructions in the L
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Chief of Materials Branch Page 3 June 6, 1973 Technical Manual regarding " Transporting, Handling and Sterili-zation of the Pulse Generator", and " Comments on Implantation Procedure (myocardial leads) ".
Applicant will establish appropriate control procedures to insure that the pulse generators are not lost or stolen.
These proce-dures will include keeping track by serial number of the location of each pulse generator and requiring that they be kept under lock when not being used.
Applicant represents that it has adequate fire protection equipment in case of emergency and that all activities will be conducted in accordance with the regulations under 10 code of Federal Regulations, Part 70.
The Applicant agrees to continue the follow-up, reporting and recovery procedures required under Medtronic's Protocol in the 1
event the Physician Responsible for the Study or any other
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physician or surgeon participating in the study is no icnger associated with Applicant.
Applicant hereby requests a license to receive, possess, store j
and implant the MedtronicTMLaurens-Alcatel Model 9000 Isotopic Pulse Generator in accordance with this application.
Signed:
Applicant:
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}lh%vp4 Moo Morris F.
George President l
Abington Memorial Hospital 1
1 Physician Responsible for Study:
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Stephen B. Knowlt n, Jr.,
M.D.
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