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 | WET-N-SOAK |
Generic Name | Accessories, soft lens products |
Regulation Number | 886.5928 |
Applicant | ADVANCED MEDICAL OPTICS, INC. 2525 DUPONT DR. IRVINE, CA 92612 |
PMA Number | P870037 |
Supplement Number | S008 |
Date Received | 06/08/1995 |
Decision Date | 02/23/1996 |
Product Code |
LPN |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR STERI-TECH, INC., P.O. BOX 1145, SALINAS, PUERTO RICO 00751 AS AN ALTERNATE CONTRACT STERILIZATION SITE, AND FOR THE USE OF 100% ETHYLENE OXIDE TO STERILIZE PLASTIC BOTTLES, ITPS, AND CAPS USED IN THE MANUFACTURE OF THE DEVICES |
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