LOMBART (POLYMACON)POLYMER BUTTONS & LATHE LL-38L

FDA Premarket Approval P880102 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

DeviceLOMBART (POLYMACON)POLYMER BUTTONS & LATHE LL-38L
Generic NameLenses, Soft Contact, Daily Wear
ApplicantLOMBART LENSES, LTD.
Date Received1991-12-20
Decision Date1993-05-05
PMAP880102
SupplementS002
Product CodeLPL 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address LOMBART LENSES, LTD. 1215 Boissevain Ave. norfolk, VA 23507

Supplemental Filings

Supplement NumberDateSupplement Type
P880102Original Filing
S002 1991-12-20 Normal 180 Day Track
S001 1991-07-08 Normal 180 Day Track

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