NEWLENSCO CLASSIC SERIES(TM) MODEL MP-2410 TIER B

FDA Premarket Approval P870075 S003

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

DeviceNEWLENSCO CLASSIC SERIES(TM) MODEL MP-2410 TIER B
Generic NameIntraocular Lens
ApplicantNEWLENSCO
Date Received1991-01-24
Decision Date1991-09-13
PMAP870075
SupplementS003
Product CodeHQL 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address NEWLENSCO 1911 Walker Ave. monrovia, CA 91016

Supplemental Filings

Supplement NumberDateSupplement Type
P870075Original Filing
S004 1991-09-24 Normal 180 Day Track
S003 1991-01-24 Normal 180 Day Track
S002
S001 1988-08-10 Panel Track

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