This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| 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 | 1987-09-08 |
| Decision Date | 1988-04-29 |
| Notice Date | 1988-06-09 |
| PMA | P870054 |
| Supplement | S |
| Product Code | DXY |
| Docket Number | 88M-0187 |
| Advisory Committee | Cardiovascular |
| 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 |