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 | MAESTRO SERIES 500 P.G. MODELS 501, 505, 509 |
| Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Applicant | CARDIAC CONTROL SYSTEMS, INC. |
| Date Received | 1988-02-17 |
| Decision Date | 1988-12-28 |
| PMA | P860027 |
| Supplement | S002 |
| Product Code | LWP |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CARDIAC CONTROL SYSTEMS, INC. 3 Commerce Blvd. palm Coast, FL 32164 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P860027 | Original Filing | |
| S012 | 1997-06-12 | Real-time Process |
| S011 | 1995-12-26 | Normal 180 Day Track |
| S010 | 1995-03-01 | Normal 180 Day Track |
| S009 | 1992-07-10 | Normal 180 Day Track |
| S008 | 1991-01-04 | Normal 180 Day Track |
| S007 | 1990-11-08 | Normal 180 Day Track |
| S006 | 1990-11-01 | Normal 180 Day Track |
| S005 | 1990-04-19 | Normal 180 Day Track |
| S004 | 1990-03-20 | Normal 180 Day Track |
| S003 | 1988-09-23 | Normal 180 Day Track |
| S002 | 1988-02-17 | Normal 180 Day Track |
| S001 | 1987-10-14 | Normal 180 Day Track |