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 change in companies from telectronics to pacesetter. The device, as modified, will be marketed under the brand name pacesetter for the dual chamber pacing models of the meta(tm) dddr model 1250h pulse generator (hereinafter referred to as the meta(tm) dddr) which is indicated where maintenance of atrio-ventricular synchrony is required. This requirement is associated with the generally accepted indication for permanaent cardiac pacing which includes, but are not limited to: 1) sick sinus node syndorme; 2)symptomatic bradycardia; 3)symptomatic a-v block; 4)recurrent stokes-adams syndrome; 5)carotid sinus syncope; and 6)suppression of tachycardia.
| Device | MODEL 1256D META MV CARDIAC PULSE GENERATOR |
| Classification Name | Implantable Pacemaker Pulse-generator |
| Generic Name | Implantable Pacemaker Pulse-generator |
| Applicant | ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI |
| Date Received | 1997-09-10 |
| Decision Date | 1997-10-07 |
| PMA | P900070 |
| Supplement | S020 |
| Product Code | DXY |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |