Approval for the ventak(r) av ii pulse generator models 1820 and 1825, model 2833 application software, version 2,8 and revised labeling to include shock energy as joules "stored" rahter than joules "delivered".
| Device | VENTAK P2 AICD MODEL 1625 & VENTAK P3 AICD MODELS 1630 AND 1635 |
| Classification Name | Implantable Cardioverter Defibrillator (non-crt) |
| Generic Name | Implantable Cardioverter Defibrillator (non-crt) |
| Applicant | BOSTON SCIENTIFIC |
| Date Received | 1997-09-30 |
| Decision Date | 1997-12-15 |
| PMA | P930035 |
| Supplement | S008 |
| Product Code | LWS |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BOSTON SCIENTIFIC 4100 Hamline Avenue North st. Paul, MN 55112 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P930035 | | Original Filing |
| S033 |
2022-11-01 |
30-day Notice |
| S032 |
2021-04-30 |
30-day Notice |
| S031 |
2021-03-08 |
30-day Notice |
| S030 |
2019-03-13 |
30-day Notice |
| S029 |
2018-03-26 |
30-day Notice |
| S028 |
2016-05-27 |
30-day Notice |
| S027 |
2014-06-30 |
30-day Notice |
| S026 |
2014-04-22 |
30-day Notice |
| S025 |
2013-08-29 |
30-day Notice |
| S024 |
2012-11-08 |
30-day Notice |
| S023 |
2012-10-10 |
30-day Notice |
| S022 |
2012-07-26 |
Real-time Process |
| S021 |
2012-03-26 |
30-day Notice |
| S020 |
2011-04-01 |
30-day Notice |
| S019 |
2009-12-18 |
30-day Notice |
| S018 |
2009-12-16 |
30-day Notice |
| S017 | | |
| S016 |
2006-04-13 |
30-day Notice |
| S015 |
2006-04-13 |
30-day Notice |
| S014 |
2004-12-03 |
30-day Notice |
| S013 |
2004-10-21 |
30-day Notice |
| S012 |
2004-04-14 |
30-day Notice |
| S011 |
2003-10-30 |
Special (immediate Track) |
| S010 |
2002-11-13 |
30-day Notice |
| S009 |
2000-12-01 |
Real-time Process |
| S008 |
1997-09-30 |
Normal 180 Day Track |
| S007 |
1996-10-16 |
Normal 180 Day Track |
| S006 |
1996-09-05 |
Normal 180 Day Track |
| S005 |
1996-05-10 |
Normal 180 Day Track |
| S004 |
1995-06-26 |
Normal 180 Day Track |
| S003 |
1995-04-06 |
Normal 180 Day Track |
| S002 |
1995-03-30 |
Normal 180 Day Track |
| S001 |
1994-11-10 |
Normal 180 Day Track |
NIH GUDID Devices