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 | META DDDR PACING SYSTEM |
| Classification Name | Implantable Pacemaker Pulse-generator |
| Generic Name | Implantable Pacemaker Pulse-generator |
| Applicant | ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI |
| Date Received | 1990-11-29 |
| Decision Date | 1992-01-30 |
| Notice Date | 1992-02-24 |
| PMA | P900070 |
| Supplement | S |
| Product Code | DXY |
| Docket Number | 92m-0054 |
| Advisory Committee | Cardiovascular |
| 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 |