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 | ORTHOVISC |
Generic Name | Acid, hyaluronic, intraarticular |
Applicant | Anika Therapeutics, Inc. 32 WIGGINS AVENUE BEDFORD, MA 01730 |
PMA Number | P030019 |
Supplement Number | S017 |
Date Received | 11/03/2010 |
Decision Date | 03/18/2011 |
Product Code |
MOZ |
Advisory Committee |
Orthopedic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE SAMPLE PREPARATION OF RAW MATERIAL HYALURONATE ACID TO BE CHANGED FROM ITS CURRENT FORMULATION TO A MORE DILUTED TEST SAMPLE. |
|
|