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 replacing the current connector top material for the above aicd model, pellethane 2363-75d polyurethane, with tecothane tt1075d-m polyurethane
Device | VENTAK(R) P MODEL 1600 |
Generic Name | Implantable Cardioverter Defibrillator (non-crt) |
Applicant | BOSTON SCIENTIFIC |
Date Received | 1995-06-26 |
Decision Date | 1996-02-20 |
PMA | P890061 |
Supplement | S011 |
Product Code | LWS |
Advisory Committee | Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/components/specifications/material |
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 |