Approval for a labeling change to include text versions and more descriptive application diagrams for using the bi-directional torque wrench (model 6942) and hex wrench (model 6501). The new labeling also specified that the device is sterilized, non-pyrogenic and single use only.
| Device | HEX WRENCH(MODEL 6501) |
| Classification Name | Implantable Cardioverter Defibrillator (non-crt) |
| Generic Name | Implantable Cardioverter Defibrillator (non-crt) |
| Applicant | BOSTON SCIENTIFIC |
| Date Received | 2003-10-30 |
| Decision Date | 2003-11-21 |
| PMA | P930035 |
| Supplement | S011 |
| Product Code | LWS |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| 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 |
|---|
| P930035 | | Original Filing |
| S033 |
2022-11-01 |
30-day Notice |
| S032 |
2021-04-30 |
30-day Notice |
| S031 |
2021-03-08 |
30-day Notice |
| S030 |
2019-03-13 |
30-day Notice |
| S029 |
2018-03-26 |
30-day Notice |
| S028 |
2016-05-27 |
30-day Notice |
| S027 |
2014-06-30 |
30-day Notice |
| S026 |
2014-04-22 |
30-day Notice |
| S025 |
2013-08-29 |
30-day Notice |
| S024 |
2012-11-08 |
30-day Notice |
| S023 |
2012-10-10 |
30-day Notice |
| S022 |
2012-07-26 |
Real-time Process |
| S021 |
2012-03-26 |
30-day Notice |
| S020 |
2011-04-01 |
30-day Notice |
| S019 |
2009-12-18 |
30-day Notice |
| S018 |
2009-12-16 |
30-day Notice |
| S017 | | |
| S016 |
2006-04-13 |
30-day Notice |
| S015 |
2006-04-13 |
30-day Notice |
| S014 |
2004-12-03 |
30-day Notice |
| S013 |
2004-10-21 |
30-day Notice |
| S012 |
2004-04-14 |
30-day Notice |
| S011 |
2003-10-30 |
Special (immediate Track) |
| S010 |
2002-11-13 |
30-day Notice |
| S009 |
2000-12-01 |
Real-time Process |
| S008 |
1997-09-30 |
Normal 180 Day Track |
| S007 |
1996-10-16 |
Normal 180 Day Track |
| S006 |
1996-09-05 |
Normal 180 Day Track |
| S005 |
1996-05-10 |
Normal 180 Day Track |
| S004 |
1995-06-26 |
Normal 180 Day Track |
| S003 |
1995-04-06 |
Normal 180 Day Track |
| S002 |
1995-03-30 |
Normal 180 Day Track |
| S001 |
1994-11-10 |
Normal 180 Day Track |
NIH GUDID Devices