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 | ULTRAVIOLET ABSORBING SILICONE POSTERIOR CHAMBER IOL'S |
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 | S027 |
Date Received | 11/19/2001 |
Decision Date | 05/01/2002 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Express GMP Supplement |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ALTERNATE STERILIZATION FACILITY LOCATED AT EDWARDS LIFESCIENCES LLC, ANASCO, PUERTO RICO. |
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