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.
Approval for the revised post-approval study protocol for the 30 mm and 40 mm bet systems. The revised post-approval study is intended to verify that the corrective actions, intended to help minimize the incidence of device failures and malfunctions seen during the premarket clinical investigations, are successful in reducing the device failure and malfunction rate.
| Device | NOVOSTE BETA-CATH SYSTEM |
| Classification Name | Intravascular Radiation Delivery System |
| Generic Name | Intravascular Radiation Delivery System |
| Applicant | BEST VASCULAR, INC |
| Date Received | 2001-08-07 |
| Decision Date | 2002-01-30 |
| PMA | P000018 |
| Supplement | S016 |
| Product Code | MOU |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BEST VASCULAR, INC 4350 International Boulevard norcross, GA 30093 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P000018 | Original Filing | |
| S050 | 2019-07-30 | Real-time Process |
| S049 | ||
| S048 | 2016-08-19 | Normal 180 Day Track |
| S047 | 2016-02-26 | 30-day Notice |
| S046 | 2014-11-20 | Normal 180 Day Track |
| S045 | 2011-06-20 | 135 Review Track For 30-day Notice |
| S044 | 2010-09-24 | Normal 180 Day Track No User Fee |
| S043 | 2006-11-28 | Normal 180 Day Track No User Fee |
| S042 | 2006-03-09 | Normal 180 Day Track No User Fee |
| S041 | 2004-06-28 | Normal 180 Day Track No User Fee |
| S040 | 2003-12-16 | Normal 180 Day Track |
| S039 | 2003-11-05 | 30-day Notice |
| S038 | 2003-10-02 | 30-day Notice |
| S037 | 2003-09-11 | 30-day Notice |
| S036 | 2003-09-10 | 30-day Notice |
| S035 | 2003-08-21 | Normal 180 Day Track |
| S034 | 2003-05-29 | 30-day Notice |
| S033 | 2003-05-12 | 30-day Notice |
| S032 | 2003-03-03 | 30-day Notice |
| S031 | 2003-02-14 | Special (immediate Track) |
| S030 | 2003-02-07 | 30-day Notice |
| S029 | 2003-01-21 | Normal 180 Day Track |
| S028 | 2003-01-06 | Normal 180 Day Track |
| S027 | 2002-10-21 | 135 Review Track For 30-day Notice |
| S026 | 2002-10-18 | Special (immediate Track) |
| S025 | 2002-10-15 | Normal 180 Day Track |
| S024 | 2002-09-03 | 30-day Notice |
| S023 | 2002-07-18 | 30-day Notice |
| S022 | 2002-06-06 | 30-day Notice |
| S021 | 2002-05-01 | Real-time Process |
| S020 | ||
| S019 | 2001-10-02 | Normal 180 Day Track |
| S018 | 2001-08-31 | Normal 180 Day Track |
| S017 | 2001-08-27 | 30-day Notice |
| S016 | 2001-08-07 | Real-time Process |
| S015 | 2001-07-31 | Normal 180 Day Track |
| S014 | 2001-06-14 | 30-day Notice |
| S013 | 2001-04-24 | Real-time Process |
| S012 | 2001-03-09 | 135 Review Track For 30-day Notice |
| S011 | 2001-02-21 | Real-time Process |
| S010 | 2001-02-15 | 30-day Notice |
| S009 | 2001-02-12 | Normal 180 Day Track |
| S008 | 2001-02-02 | Real-time Process |
| S007 | 2001-01-18 | 30-day Notice |
| S006 | 2001-01-05 | 30-day Notice |
| S005 | 2000-12-28 | Real-time Process |
| S004 | ||
| S003 | 2000-12-19 | Normal 180 Day Track |
| S002 | 2000-11-17 | Special (immediate Track) |
| S001 | 2000-11-14 | Special (immediate Track) |