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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.
 
DeviceELASTIC UVA PC IOL
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantStaar Surgical Co.
1911 Walker Ave.
Monrovia, CA 91016
PMA NumberP880091
Supplement NumberS017
Date Received07/30/1999
Decision Date09/02/1999
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  
The 30-Day Notice requested that STAAR Surgical Company be permitted to implement a Gentinge Castle Autoclave to sterilize products during the scheduled or unscheduled shutdown of the primary autoclave manufactured by Kuhlman Technologies, Inc.
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