|
Device | SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVOCES (OVD), HEALON GV, HEALON5 PRODUCTS |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | Johnson & Johnson Surgical Vision, Inc. 31 Technology Drive suite 200 Irvine, CA 92618 |
PMA Number | P810031 |
Supplement Number | S038 |
Date Received | 09/03/2010 |
Decision Date | 11/22/2010 |
Product Code |
LZP |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A LABELING CHANGE TO UPDATE THE LABELING THAT WAS APPROVED UNDER PMA SUPPLEMENT P810031/S017 TO REFLECT THE ABBOTT BRANDING GUIDELINES. |