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 | OCUCOAT(2%HYDROXYPROPYLMETHYLCELLULOSE SOLUTION) |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | Bausch & Lomb, Inc. 50 Technology Drive Irvine, CA 92618 |
PMA Number | P860047 |
Supplement Number | S012 |
Date Received | 03/20/2003 |
Decision Date | 04/16/2003 |
Product Code |
LZP |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN THE FREQUENCY OF THE FOLLOWING INCOMING INSPECTION TESTS: HPMC CONTENT, TOTAL CHLORIDES, OSMOLARITY, PARTICULATES, PROTEIN, DENSITY, HPMC VOLUME, PH AND VISCOSITY. |
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