Alternate stylet tip forming and inspection manufacturing processes that are performed at the supplier.
| Device | Ventak and Automatic Implantable Cardioverter Defibrillator (AICD) Systems |
| Generic Name | Implantable Cardioverter Defibrillator (non-crt) |
| Applicant | BOSTON SCIENTIFIC |
| Date Received | 2021-09-30 |
| Decision Date | 2021-10-04 |
| PMA | P830060 |
| Supplement | S087 |
| Product Code | LWS |
| 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 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P830060 | | Original Filing |
| S088 |
2022-11-01 |
30-day Notice |
| S087 |
2021-09-30 |
30-day Notice |
| S086 |
2021-04-30 |
30-day Notice |
| S085 |
2021-03-08 |
30-day Notice |
| S084 |
2021-02-24 |
Normal 180 Day Track No User Fee |
| S083 |
2019-03-13 |
30-day Notice |
| S082 |
2018-03-26 |
30-day Notice |
| S081 |
2016-05-27 |
30-day Notice |
| S080 |
2014-06-30 |
30-day Notice |
| S079 |
2014-04-22 |
30-day Notice |
| S078 |
2014-03-04 |
Real-time Process |
| S077 |
2014-02-21 |
Real-time Process |
| S076 |
2013-08-29 |
30-day Notice |
| S075 |
2013-05-16 |
Real-time Process |
| S074 |
2012-11-08 |
30-day Notice |
| S073 |
2012-10-10 |
30-day Notice |
| S072 |
2012-07-26 |
Real-time Process |
| S071 | | |
| S070 |
2012-03-26 |
30-day Notice |
| S069 |
2011-05-25 |
30-day Notice |
| S068 |
2011-04-01 |
30-day Notice |
| S067 |
2011-03-28 |
Real-time Process |
| S066 | | |
| S065 |
2009-12-18 |
30-day Notice |
| S064 |
2009-12-16 |
30-day Notice |
| S063 | | |
| S062 |
2009-02-24 |
Normal 180 Day Track |
| S061 | | |
| S060 |
2006-04-13 |
30-day Notice |
| S059 |
2006-04-13 |
30-day Notice |
| S058 |
2005-05-27 |
Special (immediate Track) |
| S057 |
2004-12-03 |
30-day Notice |
| S056 |
2004-10-21 |
30-day Notice |
| S055 |
2004-06-14 |
30-day Notice |
| S054 |
2004-04-14 |
30-day Notice |
| S053 |
2004-01-13 |
30-day Notice |
| S052 |
2003-10-30 |
Special (immediate Track) |
| S051 |
2002-11-13 |
30-day Notice |
| S050 | | |
| S049 |
2000-08-21 |
Normal 180 Day Track |
| S048 |
2000-04-27 |
Real-time Process |
| S047 |
2000-01-11 |
Real-time Process |
| S046 |
1999-12-16 |
Normal 180 Day Track |
| S045 |
1999-08-25 |
Normal 180 Day Track |
| S044 |
1998-11-20 |
Real-time Process |
| S043 |
1998-10-13 |
Real-time Process |
| S042 |
1996-10-16 |
Normal 180 Day Track |
| S041 |
1995-12-21 |
Normal 180 Day Track |
| S040 |
1995-02-10 |
Normal 180 Day Track |
| S039 |
1995-05-01 |
Normal 180 Day Track |
| S038 |
1995-04-06 |
Normal 180 Day Track |
| S037 |
1994-12-23 |
Normal 180 Day Track |
| S036 |
1994-12-14 |
Normal 180 Day Track |
| S035 |
1994-04-20 |
Normal 180 Day Track |
| S034 |
1993-10-19 |
Normal 180 Day Track |
| S033 |
1993-04-15 |
Normal 180 Day Track |
| S032 |
1992-08-26 |
Normal 180 Day Track |
| S031 | | |
| S030 |
1992-04-29 |
Normal 180 Day Track |
| S029 |
1991-11-22 |
Normal 180 Day Track |
| S028 |
1991-11-07 |
Normal 180 Day Track |
| S027 |
1991-09-23 |
Normal 180 Day Track |
| S026 |
1991-07-05 |
Normal 180 Day Track |
| S025 |
1991-05-15 |
Normal 180 Day Track |
| S024 |
1990-11-13 |
Normal 180 Day Track |
| S023 |
1990-09-27 |
Normal 180 Day Track |
| S022 |
1990-09-26 |
Normal 180 Day Track |
| S021 |
1990-08-15 |
Normal 180 Day Track |
| S020 |
1990-07-23 |
Normal 180 Day Track |
| S019 |
1990-05-04 |
Normal 180 Day Track |
| S018 |
1990-03-07 |
Normal 180 Day Track |
| S017 | | |
| S016 |
1990-03-01 |
Normal 180 Day Track |
| S015 |
1990-02-15 |
Normal 180 Day Track |
| S014 |
1990-02-15 |
Normal 180 Day Track |
| S013 |
1989-11-20 |
Normal 180 Day Track |
| S012 |
1989-10-31 |
Normal 180 Day Track |
| S011 |
1989-10-17 |
Normal 180 Day Track |
| S010 |
1989-10-12 |
Normal 180 Day Track |
| S009 | | |
| S008 |
1989-06-13 |
Normal 180 Day Track |
| S007 |
1988-08-15 |
Normal 180 Day Track |
| S006 |
1988-03-08 |
Normal 180 Day Track |
| S005 |
1987-09-22 |
Normal 180 Day Track |
| S004 |
1986-09-16 |
Normal 180 Day Track |
| S003 |
1986-08-06 |
Special (immediate Track) |
| S002 |
1986-02-03 |
|
| S001 |
1985-12-03 |
|
NIH GUDID Devices