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 alternative supplier of methyl methacrylate monomer.
| Device | SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT |
| Classification Name | Bone Cement |
| Generic Name | Bone Cement |
| Applicant | HOWMEDICA CORP. |
| Date Received | 1997-06-16 |
| Decision Date | 1997-08-08 |
| PMA | N17004 |
| Supplement | S009 |
| Product Code | LOD |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HOWMEDICA CORP. 359 Veterans Blvd. rutherford, NJ 07070 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N17004 | Original Filing | |
| S013 | 2000-12-01 | Real-time Process |
| S012 | 2000-05-23 | Real-time Process |
| S011 | 1998-02-03 | Normal 180 Day Track |
| S010 | 1997-10-17 | Real-time Process |
| S009 | 1997-06-16 | Normal 180 Day Track |
| S008 | 1996-11-18 | Real-time Process |
| S007 | ||
| S006 | 1994-09-26 | Normal 180 Day Track |
| S005 | 1994-02-22 | Normal 180 Day Track |
| S004 | 1993-05-21 | Normal 180 Day Track |
| S003 | 1991-10-08 | Normal 180 Day Track |
| S002 | 1990-04-30 | Normal 180 Day Track |
| S001 | 1981-03-03 |