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 | ALLERGAN(R) REWETTING DROPS |
Generic Name | Accessories, soft lens products |
Regulation Number | 886.5928 |
Applicant | ADVANCED MEDICAL OPTICS, INC. 2525 DUPONT DR. IRVINE, CA 92612 |
PMA Number | P910075 |
Supplement Number | S005 |
Date Received | 05/05/1995 |
Decision Date | 04/12/1996 |
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 ISOTRON IRELAND, LTD. LOCATED AT SRAGH INDUSTRIAL ESTATE, TULLAMORE, CO. OFFALY, IRELAND, AS AN ALTERNATE CONTRACT STERILIZATION SITE, AND FOR THE USE OF 100% ETHYLENE OXIDE TO STERILIZE THE PLASTIC BOTTLES, TIPS, AND CAPS |
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