This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| 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 | 1986-07-28 |
| Decision Date | 1987-02-27 |
| Notice Date | 1987-04-16 |
| PMA | P860027 |
| Supplement | S |
| Product Code | LWP |
| Docket Number | 87M-0085 |
| Advisory Committee | Cardiovascular |
| 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 |