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 | CONSERVE PLUS HIP RESURFACING SYSTEM NEW ENROLLMENT STUDY (NES) PROTOCOL |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/metal, Resurfacing |
| Applicant | MicroPort Orthopedics Inc. |
| Date Received | 2010-01-21 |
| Decision Date | 2010-06-21 |
| PMA | P030042 |
| Supplement | S003 |
| Product Code | NXT |
| 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 | MicroPort Orthopedics Inc. 5677 Airline Rd arlington, TN 38002 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P030042 | Original Filing | |
| S004 | 2010-08-27 | Real-time Process |
| S003 | 2010-01-21 | Normal 180 Day Track No User Fee |
| S002 | 2010-01-21 | Normal 180 Day Track No User Fee |
| S001 |