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.
Change to the procedures for inspections of materials/ components received from suppliers.
Device | VENTAK P |
Generic Name | Implantable Cardioverter Defibrillator (non-crt) |
Applicant | BOSTON SCIENTIFIC |
Date Received | 2004-10-21 |
Decision Date | 2004-11-19 |
PMA | P890061 |
Supplement | S015 |
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 |