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.
The 30-day notice requested approval for use of parametric release as an alternate to the current use of biological indicators in the release of sterilized products.
| Device | TEMPO AND META PULSE GENERATORS |
| Classification Name | Implantable Pacemaker Pulse-generator |
| Generic Name | Implantable Pacemaker Pulse-generator |
| Applicant | ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI |
| Date Received | 1998-09-09 |
| Decision Date | 1998-10-15 |
| PMA | P900070 |
| Supplement | S023 |
| Product Code | DXY |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 15900 Valley View Ct. sylmar, CA 91342 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P900070 | Original Filing | |
| S034 | 2006-06-07 | Real-time Process |
| S033 | ||
| S032 | 2006-03-30 | Real-time Process |
| S031 | 2006-02-22 | Normal 180 Day Track |
| S030 | 2006-02-16 | Normal 180 Day Track |
| S029 | ||
| S028 | 2002-12-24 | Real-time Process |
| S027 | 2000-08-11 | Normal 180 Day Track |
| S026 | 2000-01-31 | 30-day Notice |
| S025 | 1999-09-07 | Real-time Process |
| S024 | 1998-10-06 | Real-time Process |
| S023 | 1998-09-09 | 30-day Notice |
| S022 | 1998-03-06 | Normal 180 Day Track |
| S021 | 1997-09-29 | Normal 180 Day Track |
| S020 | 1997-09-10 | Real-time Process |
| S019 | 1997-04-14 | Normal 180 Day Track |
| S018 | 1997-04-08 | Normal 180 Day Track |
| S017 | 1997-02-26 | Normal 180 Day Track |
| S016 | 1997-02-11 | Normal 180 Day Track |
| S015 | 1996-11-06 | Normal 180 Day Track |
| S014 | 1996-09-16 | Normal 180 Day Track |
| S013 | ||
| S012 | 1995-12-07 | Normal 180 Day Track |
| S011 | 1995-02-06 | Normal 180 Day Track |
| S010 | 1995-01-18 | Normal 180 Day Track |
| S009 | 1994-07-29 | Normal 180 Day Track |
| S008 | ||
| S007 | 1993-11-08 | Normal 180 Day Track |
| S006 | 1993-07-01 | Normal 180 Day Track |
| S005 | 1993-06-17 | Normal 180 Day Track |
| S004 | 1993-01-27 | Normal 180 Day Track |
| S003 | 1992-10-05 | Normal 180 Day Track |
| S002 | 1992-06-19 | Normal 180 Day Track |
| S001 | 1992-06-15 | Normal 180 Day Track |