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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.
 
DeviceANTERIOR CHAMBER IOL'S
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
BAUSCH & LOMB
1400 north goodman st.
rochester, NY 14609-3547
PMA NumberP870013
Supplement NumberS011
Date Received12/23/1998
Decision Date01/28/1999
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate packaging configuration for the PMMA IOLs, manufactured at Claremont, CA facility.
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