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 of the post-approval study protocol.
| Device | STELKAST SURPASS ACETABULAR SYSTEM |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Applicant | STELKAST COMPANY |
| Date Received | 2009-10-06 |
| Decision Date | 2011-04-22 |
| PMA | P040051 |
| Supplement | S002 |
| Product Code | MRA |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Osb |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | STELKAST COMPANY 200 Hidden Valley Road mcmurray, PA 15317 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P040051 | Original Filing | |
| S002 | 2009-10-06 | Normal 180 Day Track No User Fee |
| S001 | 2007-12-17 | 135 Review Track For 30-day Notice |