NOVALENS (ROSILFOCON A)

FDA Premarket Approval P890058 S011

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

DeviceNOVALENS (ROSILFOCON A)
Generic NameLens, Contact (other Material) - Daily
ApplicantOCUTEC CORPORATION, INC.
Date Received1993-03-17
Decision Date1993-04-06
PMAP890058
SupplementS011
Product CodeHQD 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address OCUTEC CORPORATION, INC. 2700-200 Gateway Center Blvd. morrisville, NC 27560

Supplemental Filings

Supplement NumberDateSupplement Type
P890058Original Filing
S012 1993-04-07 Normal 180 Day Track
S011 1993-03-17 Normal 180 Day Track
S010 1992-10-16 Normal 180 Day Track
S009 1991-05-08 Normal 180 Day Track
S008 1991-03-07 Normal 180 Day Track
S007 1991-02-27 Normal 180 Day Track
S006 1990-12-05 30-Day Supplement
S005 1990-09-11 30-Day Supplement
S004 1990-10-16 Normal 180 Day Track
S003 1990-09-11 30-Day Supplement
S002 1990-08-27 30-Day Supplement
S001 1990-04-27 Normal 180 Day Track

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