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.
Alternate vendor for the calibrated module assembly for the micro-pace model 4553, part number 02-025-000
| Device | MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER |
| Generic Name | Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only) |
| Applicant | PACE MEDICAL |
| Date Received | 1996-01-19 |
| Decision Date | 1996-07-19 |
| PMA | P920032 |
| Supplement | S003 |
| Product Code | JOQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |