(POLYMACON) SOF-FORM II CONTACT LENSES

FDA Premarket Approval P820005 S007

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

Device(POLYMACON) SOF-FORM II CONTACT LENSES
Generic NameLenses, Soft Contact, Daily Wear
ApplicantSALVATORI OPHTHALMICS MFG. CORP.
Date Received1990-08-02
Decision Date1990-09-07
PMAP820005
SupplementS007
Product CodeLPL 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonOther Report
Expedited ReviewNo
Combination Product No
Applicant Address SALVATORI OPHTHALMICS MFG. CORP. 6416 Parkland Dr. sarasota, FL 34243

Supplemental Filings

Supplement NumberDateSupplement Type
P820005Original Filing
S007 1990-08-02 Normal 180 Day Track
S006 1989-12-29 Normal 180 Day Track
S005
S004 1983-03-04
S003 1982-12-27
S002
S001 1982-06-15

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