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® |
Generic Name | Acid, Hyaluronic, Intraarticular |
Applicant | Fidia Farmaceutici S.p.A.via Ponte Della Fabbrica 3/aabano Terme 35031 PMA NumberP180040 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 | P180040 |
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 S.p.A. via Ponte Della Fabbrica 3/a abano Terme 35031 PMA NumberP180040 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 |
---|---|---|
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 |