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. |
|
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 | S017 |
Date Received | 07/30/2015 |
Decision Date | 08/28/2015 |
Product Code |
MOZ |
Advisory Committee |
Orthopedic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement IMPLEMENTATION OF A NEW CONTROL AND ALERT SYSTEM FOR MONITORING AND RECORDING THE CRITICAL SPEEDS DURING MANUFACTURING OF A COMPONENT OF GEL-ONE®. |
|
|