|
Device | ORTHOVISC HIGH MOLECULAR WEIGHT HYALURON |
Generic Name | Acid, hyaluronic, intraarticular |
Applicant | Anika Therapeutics, Inc. 32 WIGGINS AVENUE BEDFORD, MA 01730 |
PMA Number | P030019 |
Supplement Number | S001 |
Date Received | 02/27/2004 |
Decision Date | 08/06/2004 |
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 AN ALTERNATE RAW MATERIAL SOURCE. |