ELASTIMIDE(TM) IOL MODEL AQ-2010

FDA Premarket Approval P910060 S001

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) IOL MODEL AQ-2010
Generic NameIntraocular Lens
ApplicantSTAAR SURGICAL CO.
Date Received1992-04-30
Decision Date1994-04-20
PMAP910060
SupplementS001
Product CodeHQL 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address STAAR SURGICAL CO. 1911 Walker Ave. monrovia, CA 91016

Supplemental Filings

Supplement NumberDateSupplement Type
P910060Original Filing
S001 1992-04-30 Normal 180 Day Track

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