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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.
 
Trade NameSTAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
Classification Nameintraocular lens
Generic Nameuv-absorbing posterior chamber iol
Regulation Number886.3600
ApplicantSTAAR SURGICAL CO.
PMA NumberP990013
Supplement NumberS020
Date Received05/05/2008
Decision Date06/04/2008
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to implement a new haas office milling machine at the monrovia, california manufacturing facility used for milling collamer intraocular lenses.
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