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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.
 
DeviceOPHTEC-STABLEYES CAPSULAR TENSION RING
Generic NameRing, endocapsular
ApplicantOphtec BV
Schweitzerlaan 15
Groningen 9728 NR
PMA NumberP030023
Supplement NumberS002
Date Received01/05/2012
Decision Date03/12/2012
Product Code MRJ 
Advisory Committee Ophthalmic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A NEW SUPPLIER OF A CRITICAL RAW MATERIAL.
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