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 to extend the service life of the pcba and pib components located in the transfer device to 26 months.
| Device | NOVOSTE BETA-CATH SYSTEM |
| Classification Name | Intravascular Radiation Delivery System |
| Generic Name | Intravascular Radiation Delivery System |
| Applicant | BEST VASCULAR, INC |
| Date Received | 2014-11-20 |
| Decision Date | 2016-10-06 |
| PMA | P000018 |
| Supplement | S046 |
| Product Code | MOU |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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) |