Note: 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. |
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Device | HYALGAN |
Generic Name | Acid, hyaluronic, intraarticular |
Applicant | FIDIA FARMACEUTICI SPA VIA PONTE DELLA FABBRICA 3/A ABANO TERME, PADUA (PD) 35031 |
PMA Number | P950027 |
Supplement Number | S014 |
Date Received | 08/29/2013 |
Decision Date | 09/26/2013 |
Product Code |
MOZ |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A NEW INJECTION SYRINGE (DENOTED AS ¿EZ-FILL SYRINGE¿) FOR HYALGAN® THAT INCORPORATES A TAMPER-EVIDENT CLOSURE SYSTEM CONSISTING OF A SEAL, A TIP CAP, AND A LUER LOCK. |
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