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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DevicePMMA POSTERIOR CHAMBER INTRAOCULAR LENSES
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
BAUSCH & LOMB
1400 north goodman st.
rochester, NY 14609-3547
PMA NumberP790027
Supplement NumberS068
Date Received08/30/2002
Decision Date01/27/2003
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a facility change to produce the violet compression molded (bcm) blank pmma material at bausch & lomb, inc. , wilmington, massachusetts.
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