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.
To implement the global labeling system version 3. 0 at select locations
| Device | VENTAK P |
| Generic Name | Implantable Cardioverter Defibrillator (non-crt) |
| Applicant | BOSTON SCIENTIFIC |
| Date Received | 2021-03-08 |
| Decision Date | 2021-04-02 |
| PMA | P890061 |
| Supplement | S024 |
| Product Code | LWS |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BOSTON SCIENTIFIC 4100 Hamline Avenue North st. Paul, MN 55112 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P890061 | Original Filing | |
| S024 | 2021-03-08 | 30-day Notice |
| S023 | 2013-08-29 | 30-day Notice |
| S022 | 2012-11-08 | 30-day Notice |
| S021 | 2012-10-10 | 30-day Notice |
| S020 | 2012-03-26 | 30-day Notice |
| S019 | 2011-04-01 | 30-day Notice |
| S018 | 2009-12-18 | 30-day Notice |
| S017 | 2009-12-16 | 30-day Notice |
| S016 | 2004-12-03 | 30-day Notice |
| S015 | 2004-10-21 | 30-day Notice |
| S014 | 2004-04-14 | 30-day Notice |
| S013 | 2000-08-21 | Normal 180 Day Track |
| S012 | 1996-10-16 | Normal 180 Day Track |
| S011 | 1995-06-26 | Normal 180 Day Track |
| S010 | 1995-04-06 | Normal 180 Day Track |
| S009 | 1994-12-14 | Normal 180 Day Track |
| S008 | 1993-10-19 | Normal 180 Day Track |
| S007 | ||
| S006 | 1993-04-15 | Normal 180 Day Track |
| S005 | 1992-08-26 | Normal 180 Day Track |
| S004 | ||
| S003 | 1992-04-29 | Normal 180 Day Track |
| S002 | 1991-07-05 | Normal 180 Day Track |
| S001 | 1991-05-07 | Normal 180 Day Track |