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 | IRIDOCAPSULAR INTRAOCULAR LENS |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | ALCON 6201 South Freeway Fort Worth, TX 76134-2099 |
PMA Number | P800049 |
Supplement Number | S008 |
Date Received | 08/08/1996 |
Decision Date | 09/04/1998 |
Withdrawal Date
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12/23/2004 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an alternate sterilization process using 100% ethylene oxide, an alternate microbiological monitoring system and one resteriliztion in the event of an "aborted cycle." |
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