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 a revision to the post-market study protocol
| Device | PRO OSTEON IMPLANT 500 CORALLINE HYDROXYPATITE BONE VOID FILLER (FORMERLY INTERPORE 500) |
| Generic Name | Filler, Bone Void, Non-osteoinduction |
| Applicant | INTERPORE INTL. |
| Date Received | 1996-04-29 |
| Decision Date | 1996-07-18 |
| PMA | P860005 |
| Supplement | S005 |
| Product Code | MBS |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Other Report |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | INTERPORE INTL. 181 Technology Dr. irvine, CA 92618-2402 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P860005 | Original Filing | |
| S012 | 2001-12-04 | Normal 180 Day Track |
| S011 | 1999-04-22 | Normal 180 Day Track |
| S010 | 1997-11-18 | Normal 180 Day Track |
| S009 | 1997-10-27 | Normal 180 Day Track |
| S008 | 1997-08-28 | Normal 180 Day Track |
| S007 | 1997-05-15 | Normal 180 Day Track |
| S006 | ||
| S005 | 1996-04-29 | Normal 180 Day Track |
| S004 | 1994-02-22 | Normal 180 Day Track |
| S003 | 1993-10-15 | Normal 180 Day Track |
| S002 | 1993-03-23 | Normal 180 Day Track |
| S001 | 1993-02-08 | Normal 180 Day Track |