SEREINE CONTACT LENS CLEANER (NEW PRESERVATIVE)

FDA Premarket Approval P870050 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

Approval for an expansion of the indicatiosn for use of the subject devices to include fluorosilicone acrylate rigid gas permeable contact lenses.

DeviceSEREINE CONTACT LENS CLEANER (NEW PRESERVATIVE)
Generic NameAccessories, Soft Lens Products
ApplicantTRP COMPANY
Date Received1997-04-22
Decision Date1997-10-15
PMAP870050
SupplementS007
Product CodeLPN 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address TRP COMPANY 1575 Delucci Lane #115 reno, NV 89502

Supplemental Filings

Supplement NumberDateSupplement Type
P870050Original Filing
S007 1997-04-22 Normal 180 Day Track
S006 1996-06-04 Normal 180 Day Track
S005
S004
S003 1991-11-19 Normal 180 Day Track
S002
S001 1990-07-10 Normal 180 Day Track

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