Expansion of the release criteria of final, finished devices to accept those that have a homogenously opaque appearance
| Device | Cartiva Synthetic Cartilage Implant |
| Classification Name | Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant |
| Generic Name | Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant |
| Applicant | Cartiva, Inc |
| Date Received | 2019-10-30 |
| Decision Date | 2019-11-26 |
| PMA | P150017 |
| Supplement | S014 |
| Product Code | PNW |
| Advisory Committee | Orthopedic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Cartiva, Inc 6120 Windward Parkway suite 220 alpharetta, GA 30005 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P150017 | | Original Filing |
| S015 |
2021-06-30 |
Normal 180 Day Track No User Fee |
| S014 |
2019-10-30 |
30-day Notice |
| S013 | | |
| S012 |
2019-02-22 |
Special (immediate Track) |
| S011 | | |
| S010 | | |
| S009 |
2018-06-06 |
30-day Notice |
| S008 |
2018-06-04 |
30-day Notice |
| S007 |
2017-11-15 |
Normal 180 Day Track No User Fee |
| S006 |
2017-10-13 |
30-day Notice |
| S005 |
2017-01-31 |
Special (immediate Track) |
| S004 |
2016-12-06 |
30-day Notice |
| S003 |
2016-08-15 |
Real-time Process |
| S002 |
2016-08-01 |
Normal 180 Day Track No User Fee |
| S001 |
2016-08-01 |
30-day Notice |
NIH GUDID Devices