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 | CCS MODEL 325 PACEMAKER SYSTEM |
| Generic Name | Implantable Pacemaker Pulse-generator |
| Applicant | CARDIAC CONTROL SYSTEMS, INC. |
| Date Received | 1993-10-04 |
| Decision Date | 1994-12-02 |
| PMA | P890039 |
| Supplement | S012 |
| Product Code | DXY |
| 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 |
|---|---|---|
| P890039 | Original Filing | |
| S016 | 1996-07-19 | Normal 180 Day Track |
| S015 | 1995-12-26 | Normal 180 Day Track |
| S014 | 1995-03-23 | Normal 180 Day Track |
| S013 | 1994-04-07 | Normal 180 Day Track |
| S012 | 1993-10-04 | Normal 180 Day Track |
| S011 | 1993-04-08 | Normal 180 Day Track |
| S010 | 1992-08-13 | Normal 180 Day Track |
| S009 | 1992-06-15 | Normal 180 Day Track |
| S008 | 1992-06-04 | Normal 180 Day Track |
| S007 | 1992-06-03 | Normal 180 Day Track |
| S006 | 1992-03-30 | Normal 180 Day Track |
| S005 | 1991-09-03 | Normal 180 Day Track |
| S004 | 1991-09-03 | Normal 180 Day Track |
| S003 | 1991-04-04 | Normal 180 Day Track |
| S002 | 1991-01-04 | Normal 180 Day Track |
| S001 | 1990-12-17 | Normal 180 Day Track |