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 the addition of an independent inspector to perform visual check of the s-rom femoral stem component sterile packaging.
| Device | PINNACLE COMPLETE ACETABULAR HIP SYSTEM |
| Generic Name | Prosthesis, Hip, Semi-constrained, Ceramic-on-metal Articulation |
| Applicant | DEPUY ORTHOPAEDICS, INC. |
| Date Received | 2012-08-03 |
| Decision Date | 2012-09-06 |
| PMA | P090002 |
| Supplement | S005 |
| Product Code | OVO |
| Advisory Committee | Orthopedic |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DEPUY ORTHOPAEDICS, INC. p.o Box 988 700 Orthopaedic Drive warsaw, IN 46581-0988 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P090002 | Original Filing | |
| S009 | 2013-03-12 | 135 Review Track For 30-day Notice |
| S008 | ||
| S007 | 2012-11-28 | Special (immediate Track) |
| S006 | 2012-10-25 | 30-day Notice |
| S005 | 2012-08-03 | Special (immediate Track) |
| S004 | 2012-05-18 | 30-day Notice |
| S003 | 2012-03-27 | 30-day Notice |
| S002 | 2012-01-19 | Real-time Process |
| S001 | 2011-09-07 | Normal 180 Day Track No User Fee |