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 | TRILURON® (sodium hyaluronate) |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | Fidia Farmaceutici S.p.A.via Ponte Della Fabbrica 3/aabano Terme 35031 PMA NumberP180040 Supplement NumberS004 Date Received12/23/2022 Decision Date01/19/2023 Product Code MOZ Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-12-23 |
| Decision Date | 2023-01-19 |
| PMA | P180040 |
| Supplement | S004 |
| 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 S.p.A. via Ponte Della Fabbrica 3/a abano Terme 35031 PMA NumberP180040 Supplement NumberS004 Date Received12/23/2022 Decision Date01/19/2023 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 To The Manufacturing Procedure, Including Methods For Filtration And Washes For The Sodium Hyaluronate Bulk Powder |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P180040 | Original Filing | |
| S004 | 2022-12-23 | 30-day Notice |
| S003 | 2022-09-08 | 30-day Notice |
| S002 | 2022-07-11 | 30-day Notice |
| S001 |
| Device ID | PMA | Supp |
|---|---|---|
| M71389122087901SAM1 | P180040 | 000 |
| M71389122087901A1 | P180040 | 000 |