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 | CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K |
| Generic Name | Permanent Pacemaker Electrode |
| Applicant | PACESETTER SYSTEMS |
| Date Received | 1991-03-29 |
| Decision Date | 1994-05-25 |
| PMA | P800041 |
| Supplement | S011 |
| Product Code | DTB |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | PACESETTER SYSTEMS 15900 Valleyview Court p.o. Box 9221 sylmar, CA 91392-9221 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P800041 | Original Filing | |
| S015 | 1995-10-02 | Normal 180 Day Track |
| S014 | 1993-11-26 | Normal 180 Day Track |
| S013 | ||
| S012 | 1992-02-11 | Normal 180 Day Track |
| S011 | 1991-03-29 | Normal 180 Day Track |
| S010 | 1990-10-24 | Special (immediate Track) |
| S009 | 1990-03-14 | Normal 180 Day Track |
| S008 | 1989-05-19 | Normal 180 Day Track |
| S007 | 1987-01-09 | Normal 180 Day Track |
| S006 | 1986-08-12 | Normal 180 Day Track |
| S005 | 1985-10-17 | |
| S004 | ||
| S003 | 1984-11-19 | |
| S002 | 1983-08-18 | |
| S001 | 1982-12-17 | Normal 180 Day Track |