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 | GEL-ONE |
Generic Name | Acid, hyaluronic, intraarticular |
Applicant | SEIKAGAKU CORP. 6-1, MARUNOUCHI 1-CHOME, CHIYODA-KU TOKYO 100-0-0005 |
PMA Number | P080020 |
Supplement Number | S014 |
Date Received | 05/05/2015 |
Decision Date | 08/03/2015 |
Product Code |
MOZ |
Advisory Committee |
Orthopedic |
Clinical Trials | NCT00449696
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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 PACKAGE INSERT AND THE PATIENT INFORMATION FOR GEL-ONE® AS FOLLOWS: 1) REVISION OF THE STATEMENT, THE SAFETY AND EFFECTIVENESS OF A REPEAT TREATMENT CYCLE OF GEL-ONE® HAVE NOT BEEN ESTABLISHED. TO THE STATEMENT, THE EFFECTIVENESS OF REPEAT TREATMENT CYCLES OF GEL-ONE® HAS NOT BEEN ESTABLISHED; AND 2) CITATION OF CLINICAL STUDY DATA FOR RETREATMENT WITH GEL-ONE® IN SUPPORT OF THE REVISION OF THIS STATEMENT AS DESCRIBED ABOVE. |
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