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 recipe and addition of a new sterilization release mechanism.
Device | SELUTE Pacing Lead Family |
Generic Name | Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes |
Applicant | BOSTON SCIENTIFIC |
Date Received | 2016-05-27 |
Decision Date | 2016-06-23 |
PMA | P950001 |
Supplement | S028 |
Product Code | NVN |
Advisory Committee | Cardiovascular |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | Yes |
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 |