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 | HEALON, HEALON GV AND HEALON5 SODIUM HYLAURONATE OPHTHALMIC VISCOELASTIC DEVICES |
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 | S031 |
Date Received | 09/29/2006 |
Decision Date | 08/16/2007 |
Product Code |
LZP |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE TRANSFER AND EXPANSION OF THE QUALITY CONTROL MICROBIOLOGY LABORATORY USED FOR THE HEALON, HEALON GV AND HEALON5 SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES. THE TRANSFER INCLUDES TEST METHODS, PERSONNEL, AND EQUIPMENT FROM BUILDING 16 TO BUILDING 23 LOCATED IN UPPSALA, SWEDEN. |
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