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 | EUFLEXXA 1% SODIUM HYALURONATE |
Generic Name | Acid, hyaluronic, intraarticular |
Applicant | FERRING PHARMACEUTICALS, INC. 100 INTERPACE PARKWAY PARSIPPANY, NJ 07054 |
PMA Number | P010029 |
Supplement Number | S006 |
Date Received | 03/22/2007 |
Decision Date | 07/11/2007 |
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 SYRINGE TIP CAP MATERIAL CHANGE FROM NATURAL RUBBER TO A SYNTHETIC RUBBER FORMULATION. |
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