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.
Approval for the pacesetter, inc. , model 3070b private label version of the pace medical model 4575
| Device | MICRO-PACE MODEL 4553 DUAL CHAMBER DDD TEMPORARY CARDIAC PACEMAKER |
| Generic Name | Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only) |
| Applicant | PACE MEDICAL |
| Date Received | 1995-11-27 |
| Decision Date | 1996-04-26 |
| PMA | P920032 |
| Supplement | S002 |
| Product Code | JOQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | PACE MEDICAL 391 Totten Pond Rd. waltham, MA 02451 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P920032 | Original Filing | |
| S008 | 2001-08-16 | Normal 180 Day Track |
| S007 | 2001-04-24 | Normal 180 Day Track |
| S006 | 2001-01-18 | Normal 180 Day Track |
| S005 | 1999-06-25 | Normal 180 Day Track |
| S004 | 1998-01-30 | Normal 180 Day Track |
| S003 | 1996-01-19 | Normal 180 Day Track |
| S002 | 1995-11-27 | Normal 180 Day Track |
| S001 | 1994-12-06 | Normal 180 Day Track |