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

FDA Premarket Approval P900048

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

DeviceELASTIMIDE(TM) SILICONE MODIFIED J-LOOP POST. CHAM
Generic NameIntraocular Lens
ApplicantSTAAR SURGICAL CO.
Date Received1990-07-02
Decision Date1991-09-17
Notice Date1991-10-11
PMAP900048
SupplementS
Product CodeHQL 
Docket Number91M-0376
Advisory CommitteeOphthalmic
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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