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.
Device | MURINE LUBRICATING & REWETTING DROPS(CLEAR EYES ) |
Generic Name | Accessories, Soft Lens Products |
Applicant | Abbott Laboratories |
Date Received | 1992-08-13 |
Decision Date | 1994-04-14 |
PMA | P880056 |
Supplement | S002 |
Product Code | LPN |
Advisory Committee | Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
Expedited Review | No |
Combination Product | No |
Applicant Address | Abbott Laboratories 625 Cleveland Ave. columbus, OH 43215 |
Supplement Number | Date | Supplement Type |
---|---|---|
P880056 | Original Filing | |
S002 | 1992-08-13 | Normal 180 Day Track |
S001 | 1989-04-21 | Normal 180 Day Track |
Device ID | PMA | Supp |
---|---|---|
00678112664771 | P880056 | 002 |