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.
Alternate sterilization facility located at cosmed of illinois, 1160 northpoint blvd. , waukegan, il 60085 - this supplement reviewed under the pilot program and the approval only applies to the request for a new sterilization site
Device | SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285 |
Generic Name | Permanent Pacemaker Electrode |
Applicant | BOSTON SCIENTIFIC |
Date Received | 1996-10-16 |
Decision Date | 1996-11-12 |
PMA | P950001 |
Supplement | S001 |
Product Code | DTB |
Advisory Committee | Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location 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 |