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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.
 
DevicePOSTERIOR CHAMBER INTRAOCULAR LENSES
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantAaren Scientific
4290 E. Brickell St.
Bldg. A
Ontario, CA 91761
PMA NumberP970034
Supplement NumberS005
Date Received02/14/2000
Decision Date03/27/2000
Withdrawal Date08/20/2014
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 reducing the frequency of ethylene chlorohydrin residual testing from a quarterly basis to an annual basis.
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