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 | STAARVISC II & SHELLGEL SODIUM HYAURONATE |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | Anika Therapeutics, Inc. 32 WIGGINS AVENUE BEDFORD, MA 01730 |
PMA Number | P000046 |
Supplement Number | S015 |
Date Received | 05/27/2009 |
Decision Date | 03/27/2012 |
Product Code |
LZP |
Advisory Committee |
Ophthalmic |
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 MANUFACTURING SITE CHANGE FROM THE PREVIOUS FACILITY IN WEST CUMMINGS PARK, WOBURN, MASSACHUSETTS TO THE NEW FACILITY LOCATED IN BEDFORD, MASSACHUSETTS. IN ADDITION, THE SUPPLEMENT REQUESTED APPROVAL TO CHANGE THE TERMINAL STERILIZATION METHOD OF THE PRODUCT FROM E-BEAM CONTROLLED DEPTH STERILIZATION TO VAPORIZED HYDROGEN PEROXIDE (VHP) GAS STERILIZATION. |
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