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 | OXYCEL |
Generic Name | Agent, Absorbable Hemostatic, Non-collagen Based |
Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
Date Received | 1982-06-29 |
Decision Date | 1982-12-17 |
PMA | N5798 |
Supplement | S003 |
Product Code | LMG |
Advisory Committee | General & Plastic Surgery |
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 |
---|---|---|
N5798 | Original Filing | |
S007 | 1995-02-16 | Normal 180 Day Track |
S006 | 1990-12-19 | Normal 180 Day Track |
S005 | 1988-09-21 | Normal 180 Day Track |
S004 | 1983-04-21 | |
S003 | 1982-06-29 | |
S002 | 1980-10-29 | |
S001 | 1980-10-27 |