This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR |
| Classification Name | Implantable Pacemaker Pulse-generator |
| Generic Name | Implantable Pacemaker Pulse-generator |
| Applicant | COOK PACEMAKER CORP. |
| Date Received | 1989-02-13 |
| Decision Date | 1989-06-20 |
| PMA | P870054 |
| Supplement | S004 |
| Product Code | DXY |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | COOK PACEMAKER CORP. route 66 River Rd. p.o. Box 529 leechburg, PA 15656 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P870054 | Original Filing | |
| S014 | 1995-06-08 | Normal 180 Day Track |
| S013 | ||
| S012 | ||
| S011 | 1990-03-05 | Normal 180 Day Track |
| S010 | 1990-02-23 | Normal 180 Day Track |
| S009 | 1989-12-20 | Normal 180 Day Track |
| S008 | ||
| S007 | ||
| S006 | 1989-04-25 | Normal 180 Day Track |
| S005 | 1989-03-06 | Normal 180 Day Track |
| S004 | 1989-02-13 | Normal 180 Day Track |
| S003 | 1989-01-23 | Normal 180 Day Track |
| S002 | 1989-01-17 | Normal 180 Day Track |
| S001 | 1988-11-10 | Normal 180 Day Track |