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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.
 
DeviceCHANGE IN MANUFACTURING PROCESS TO CLEAN EYE
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantEyetech, LLC
7016 6th St. N.
Oakdale, MN 55128
PMA NumberP880082
Supplement NumberS018
Date Received06/14/1995
Decision Date09/28/1995
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE USE OF A NEW CLEANING AGENT
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