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.
| Device | HYMOVIS® |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | FIDIA FARMACEUTICIponte Della Fabbrica 3/aabano Terme 35031 PMA NumberP150010 Supplement NumberS002 Date Received07/11/2022 Decision Date08/08/2022 Product Code MOZ Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-07-11 |
| Decision Date | 2022-08-08 |
| PMA | P150010 |
| Supplement | S002 |
| Product Code | MOZ |
| Advisory Committee | Orthopedic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | FIDIA FARMACEUTICI ponte Della Fabbrica 3/a abano Terme 35031 PMA NumberP150010 Supplement NumberS002 Date Received07/11/2022 Decision Date08/08/2022 Product Code MOZ Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement a Change From Manual To Automated Syringe Quality Inspection |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P150010 | Original Filing | |
| S002 | 2022-07-11 | 30-day Notice |
| S001 | 2016-10-24 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| M71389122049663SAM1 | P150010 | 000 |
| M713891220496010 | P150010 | 000 |