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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
4290 east brickell st, bldg a
ontario, CA 91761
PMA NumberP970034
Supplement NumberS001
Date Received10/22/1998
Decision Date11/20/1998
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30-day Notice requested approval to introduce a manufacturing process change for the device. The nature of the change is to use an alternate sterilization chambera t Griffith MicroScience, the same sterilization contractor approved in the firm's original PMA. Griffith is upgrading the chamber that was previously used. Some of the parameters of the sterilization process are being changed. The changes include reduction of the minimum preconditioning time, specification of the transfer time to move the load from the preconditioning room into the sterilization chamber, use of a larger sterilization chamber, use of a computer-controlled process versus a manually-controlled process and the addition of post-ethylene oxide exposure vacuum dwell times.