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 minor changes to packaging and labeling of the product.
| Device | SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT |
| Classification Name | Bone Cement |
| Generic Name | Bone Cement |
| Applicant | HOWMEDICA CORP. |
| Date Received | 1996-11-18 |
| Decision Date | 1996-12-18 |
| PMA | N17004 |
| Supplement | S008 |
| Product Code | LOD |
| Advisory Committee | Orthopedic |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |