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.
| Device | Ventak® P2 System |
| Generic Name | Implantable Cardioverter Defibrillator (non-crt) |
| Applicant | BOSTON SCIENTIFIC4100 Hamline Avenue Northst. Paul, MN 55112 PMA NumberP930035 Supplement NumberS033 Date Received11/01/2022 Decision Date11/02/2022 Product Code LWS Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-11-01 |
| Decision Date | 2022-11-02 |
| PMA | P930035 |
| Supplement | S033 |
| 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 PMA NumberP930035 Supplement NumberS033 Date Received11/01/2022 Decision Date11/02/2022 Product Code LWS Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement to Replace Laser Printers, Finished Goods Box And Tray Label Stock |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00802526489228 | P930035 | 011 |
| 00802526605901 | P930035 | 028 |