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 in the manufacturing process to the parametric release method, which involves sterile product release based on conformance to pre-defined sterilization parameters rather than a release based on demonstrating no growth in biological indicator.
Device | SELUTE LEADS AND ACCESSORIES |
Generic Name | Permanent Pacemaker Electrode |
Applicant | BOSTON SCIENTIFIC |
Date Received | 2002-11-13 |
Decision Date | 2002-12-13 |
PMA | P950001 |
Supplement | S009 |
Product Code | DTB |
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 |
---|---|---|
P950001 | Original Filing | |
S029 | 2021-03-08 | 30-day Notice |
S028 | 2016-05-27 | 30-day Notice |
S027 | 2014-06-30 | 30-day Notice |
S026 | 2013-08-29 | 30-day Notice |
S025 | 2012-11-08 | 30-day Notice |
S024 | 2012-10-02 | 30-day Notice |
S023 | 2012-03-26 | 30-day Notice |
S022 | 2011-04-01 | 30-day Notice |
S021 | 2009-12-18 | 30-day Notice |
S020 | 2009-12-16 | 30-day Notice |
S019 | ||
S018 | ||
S017 | 2006-04-13 | 30-day Notice |
S016 | 2006-04-13 | 30-day Notice |
S015 | 2005-10-06 | Real-time Process |
S014 | 2005-02-24 | 30-day Notice |
S013 | 2004-12-03 | 30-day Notice |
S012 | 2004-10-21 | 30-day Notice |
S011 | 2004-04-14 | 30-day Notice |
S010 | 2004-01-13 | 30-day Notice |
S009 | 2002-11-13 | 30-day Notice |
S008 | 2000-08-21 | Normal 180 Day Track |
S007 | 2000-05-31 | Real-time Process |
S006 | 2000-04-17 | Real-time Process |
S005 | 1999-12-16 | Normal 180 Day Track |
S004 | 1999-11-15 | Normal 180 Day Track |
S003 | 1997-10-01 | Normal 180 Day Track |
S002 | 1997-04-03 | Normal 180 Day Track |
S001 | 1996-10-16 | Normal 180 Day Track |