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 | S018 |
Date Received | 08/31/2015 |
Decision Date | 11/25/2015 |
Product Code |
MOZ |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO THE MANUFACTURING AND STORING OF GEL-ONE® TO ALLOW FOR THE REFRIGERATION (5°C ± 3°C) OF IN-PROCESS PRODUCT (I.E. PRODUCT THAT HAS NOT YET BEEN PACKAGED AND LABELED) FOR A MAXIMUM OF 6 MONTHS FOLLOWING THE DATE OF TERMINAL STEAM STERILIZATION AND PRIOR TO INITIATION OF THE PRODUCT¿S PREVIOUSLY ESTABLISHED 12 MONTH SHELF LIFE WHEN STORED BELOW 25°C (WITHOUT FREEZING). |
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