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.
| Device | PROGRAMALITH(TM) MODEL 223 PULSE GENERATOR & 398 P |
| Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Applicant | PACESETTER SYSTEMS |
| Date Received | 1983-03-25 |
| Decision Date | 1983-05-03 |
| PMA | P820023 |
| Supplement | S002 |
| Product Code | LWP |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | PACESETTER SYSTEMS 12884 Bradley Ave. sylmar, CA 91342 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P820023 | Original Filing | |
| S005 | 1983-11-03 | |
| S004 | 1983-08-09 | |
| S003 | 1983-06-06 | |
| S002 | 1983-03-25 | |
| S001 |