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 is for an alternate vendor located at princeton technology, inc. , 12 park avenue, hudson, new hampshire.
| Device | MICRO-PACE DUAL-CHAMBER, DDD, TEMPORARY CARDIAC PACEMAKER |
| Generic Name | Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only) |
| Applicant | PACE MEDICAL |
| Date Received | 1999-06-25 |
| Decision Date | 2000-02-02 |
| PMA | P920032 |
| Supplement | S005 |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| 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 |