Approval for lead stabilizer kit 6503 and lead cap kit 6504, which are accessory kits intended to be used with the boston scientific corporation (bsc) lead products approved in the devices.
Device | SWEET TIP RX/ FLEXTEND LEAD FAMILY |
Classification Name | Permanent Defibrillator Electrodes |
Generic Name | Permanent Defibrillator Electrodes |
Applicant | BOSTON SCIENTIFIC |
Date Received | 2013-05-16 |
Decision Date | 2013-08-07 |
PMA | P960006 |
Supplement | S039 |
Product Code | NVY |
Advisory Committee | Cardiovascular |
Supplement Type | Real-time Process |
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 |
Supplemental Filings
Supplement Number | Date | Supplement Type |
P960006 | | Original Filing |
S055 |
2022-11-01 |
30-day Notice |
S054 |
2021-09-30 |
30-day Notice |
S053 |
2021-09-01 |
30-day Notice |
S052 |
2021-04-30 |
30-day Notice |
S051 |
2021-03-08 |
30-day Notice |
S050 |
2021-01-11 |
30-day Notice |
S049 |
2019-03-13 |
30-day Notice |
S048 |
2018-07-13 |
30-day Notice |
S047 |
2018-03-26 |
30-day Notice |
S046 |
2016-05-27 |
30-day Notice |
S045 | | |
S044 |
2015-06-22 |
30-day Notice |
S043 |
2014-06-30 |
30-day Notice |
S042 |
2014-04-22 |
30-day Notice |
S041 |
2014-01-28 |
Real-time Process |
S040 |
2013-08-29 |
30-day Notice |
S039 |
2013-05-16 |
Real-time Process |
S038 |
2013-03-19 |
Real-time Process |
S037 |
2012-11-08 |
30-day Notice |
S036 |
2012-10-02 |
30-day Notice |
S035 |
2012-09-04 |
30-day Notice |
S034 |
2012-06-19 |
30-day Notice |
S033 |
2012-03-26 |
30-day Notice |
S032 |
2012-01-24 |
30-day Notice |
S031 |
2011-05-25 |
30-day Notice |
S030 |
2011-04-01 |
30-day Notice |
S029 |
2010-12-01 |
135 Review Track For 30-day Notice |
S028 | | |
S027 |
2010-09-21 |
30-day Notice |
S026 |
2009-12-18 |
30-day Notice |
S025 |
2009-12-16 |
30-day Notice |
S024 | | |
S023 | | |
S022 |
2007-05-07 |
30-day Notice |
S021 |
2006-04-13 |
30-day Notice |
S020 |
2006-04-13 |
30-day Notice |
S019 |
2005-11-09 |
30-day Notice |
S018 | | |
S017 |
2005-08-01 |
30-day Notice |
S016 |
2005-07-05 |
30-day Notice |
S015 |
2005-04-13 |
30-day Notice |
S014 |
2005-02-24 |
30-day Notice |
S013 |
2004-12-03 |
30-day Notice |
S012 |
2004-10-21 |
30-day Notice |
S011 | | |
S010 |
2004-04-14 |
30-day Notice |
S009 |
2004-01-13 |
30-day Notice |
S008 |
2003-03-20 |
Real-time Process |
S007 |
2002-11-13 |
30-day Notice |
S006 | | |
S005 |
2001-07-11 |
Normal 180 Day Track |
S004 |
2000-08-21 |
Normal 180 Day Track |
S003 |
1999-12-16 |
Normal 180 Day Track |
S002 |
1998-10-29 |
Real-time Process |
S001 |
1998-10-02 |
Normal 180 Day Track |
NIH GUDID Devices