MURINE LUBRICATING & REWETTING DROPS(CLEAR EYES )

FDA Premarket Approval P880056 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

DeviceMURINE LUBRICATING & REWETTING DROPS(CLEAR EYES )
Generic NameAccessories, Soft Lens Products
ApplicantAbbott Laboratories
Date Received1992-08-13
Decision Date1994-04-14
PMAP880056
SupplementS002
Product CodeLPN 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Abbott Laboratories 625 Cleveland Ave. columbus, OH 43215

Supplemental Filings

Supplement NumberDateSupplement Type
P880056Original Filing
S002 1992-08-13 Normal 180 Day Track
S001 1989-04-21 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00678112664771 P880056 002

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