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 to modify the temporary pacemakers by replacing the zener diodes used for protecting the internal electronics from high voltage transients with a transient voltage suppressor.
| Device | MODEL4553 MICRO-PACE,DUAL-CHAMBER,DDD TEMPORARY CARDIAC PACEMAKER |
| Generic Name | Pulse-generator, Pacemaker, External |
| Applicant | PACE MEDICAL |
| Date Received | 2001-01-18 |
| Decision Date | 2001-04-06 |
| PMA | P920032 |
| Supplement | S006 |
| 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 |