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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.
 
DeviceSTAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantStarr Surgical Co.
1911 Walker Ave.
Monrovia, CA 91016
PMA NumberP990013
Supplement NumberS016
Date Received03/20/2008
Decision Date04/16/2008
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  
IMPLEMENTATION OF A MODIFIED MANUFACTURING PROCESS FOR THE COLLAMER LENSES MANUFACTURED AT THE SWITZERLAND FACILITY.
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