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 | GELSYN-3 |
Generic Name | Acid, hyaluronic, intraarticular |
Applicant | IBSA INSTITUT BIOCHIMIQUE SA VIA AL PONTE 13, CH-6903 LUGANO TICINO 6903 |
PMA Number | P110005 |
Supplement Number | S002 |
Date Received | 01/19/2017 |
Decision Date | 03/10/2017 |
Product Code |
MOZ |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for revisions to the labeling of GELSYN-3 as follows: 1) Deletion of the statement, The safety and effectiveness of repeat treatment cycles of Gel-Syn have not been established from the Patient Information leaflet and addition of the statement, The effectiveness of repeat treatment cycles of GELSYN-3 has not been established. to the Product Information and Patient Information leaflets; and2) Addition of the statements, Adverse experience data from clinical use does not show an increased safety risk from retreatment with GELSYN-3. The frequency and severity of adverse events occurring during repeat treatment cycles did not increase over that reported for a single treatment cycle to the Product Information and Patient Information leaflets. |
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