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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameUV-PMMA PCL'S
Classification Nameintraocular lens
Generic Nameuv-absorbing posterior chamber intraocular lenses
Regulation Number886.3600
ApplicantOPHTHALMIC INNOVATIONS INTL., INC.
PMA NumberP970034
Supplement NumberS003
Date Received03/23/1999
Decision Date04/16/1999
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30-day notice requested introduction of a manufacturing process change to use an alternate sterilization chamber (chamber #1) at griffith microscience, the same sterilization contractor approved in the original pma. Griffith is upgrading the chamber that was previously used. The proposed cycle is nearly identical to the currently-approved cycle for chamber #8, both chambers will use the computer-controlled process; the primary differences are that the chamber is smaller and an additional air wash with vacuum hold have beed added after the gas-dwell phase.
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