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 | 5ODEL SI-11NB UV ABSORBING SILICONE POSTERIOR IOL |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | Johnson & Johnson Surgical Vision, Inc. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P880081 |
Supplement Number | S018 |
Date Received | 04/04/1995 |
Decision Date | 07/28/1995 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR SINGLE-POUCH TYVEK PACKAGING OF LENSES PRODUCED IN IRVINE, CA & ANASCO, PR, STERILZATION OF LENSES USING PREVIOUSLY APPROVED 100% ETO STERILIZATION CYCLES & A 5 YEAR SHELF LIFE FOR SINGLE POUCH/100% ETO STERILIZED LENSES |
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