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 modifications to the user's manual, user's guide and customer training to include additional information on scenarios where the beta-rail 3. 5f delivery catheter tip may be subjected to excessive force and the techniques for avoiding and/or resolving these scenarios.
| Device | NOVOSTE BETA-CATH 3.5F SYSTEM |
| Classification Name | Intravascular Radiation Delivery System |
| Generic Name | Intravascular Radiation Delivery System |
| Applicant | BEST VASCULAR, INC |
| Date Received | 2002-10-18 |
| Decision Date | 2002-11-13 |
| PMA | P000018 |
| Supplement | S026 |
| Product Code | MOU |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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) |