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 | MINI BALLOON |
| Classification Name | Device, Vascular, For Promoting Embolization |
| Generic Name | Device, Vascular, For Promoting Embolization |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
| Date Received | 1988-05-31 |
| Decision Date | 1988-10-18 |
| PMA | P780011 |
| Supplement | S011 |
| Product Code | KRD |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Other Report |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC one Becton Dr. franklin Lakes, NJ 07417-1880 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P780011 | Original Filing | |
| S012 | 1989-08-29 | Normal 180 Day Track |
| S011 | 1988-05-31 | Normal 180 Day Track |
| S010 | 1987-05-01 | Normal 180 Day Track |
| S009 | ||
| S008 | ||
| S007 | 1984-08-16 | |
| S006 | 1982-05-03 | |
| S005 | 1981-05-12 | |
| S004 | 1981-02-26 | |
| S003 | 1981-02-26 | |
| S002 | ||
| S001 | 1981-02-26 |