ELASTIMIDE(TM) SILICONE MODIFIED C-LOOP POST. CHAM

FDA Premarket Approval P900048 S002

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.

Pre-market Approval Supplement Details

DeviceELASTIMIDE(TM) SILICONE MODIFIED C-LOOP POST. CHAM
Generic NameIntraocular Lens
ApplicantSTAAR SURGICAL CO.
Date Received1992-12-28
Decision Date1993-08-23
PMAP900048
SupplementS002
Product CodeHQL 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address STAAR SURGICAL CO. 1911 Walker Ave. monrovia, CA 91016

Supplemental Filings

Supplement NumberDateSupplement Type
P900048Original Filing
S002 1992-12-28 Normal 180 Day Track
S001 1991-03-06 Normal 180 Day Track

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