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 for the mawstro ii model 533 pacemaker system
| Device | MAESTRO(R) II MODEL 533 PACEMAKER SYSTEM |
| Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Applicant | CARDIAC CONTROL SYSTEMS, INC. |
| Date Received | 1995-03-01 |
| Decision Date | 1995-09-26 |
| PMA | P860027 |
| Supplement | S010 |
| 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 |