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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.
 
DeviceCOLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantStarr Surgical Co.
1911 Walker Ave.
Monrovia, CA 91016
PMA NumberP990013
Supplement NumberS034
Date Received03/13/2017
Decision Date04/06/2017
Product Code HQL 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Modify the hydration step for the Collamer IOL Models CQ2015A and CC4204A and to remove the cometic inspection step for the Collamer IOL Model CC4204A that was performed as part of the hydration process.
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