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 | CIBA VISION LENS DROPS |
Generic Name | Accessories, Soft Lens Products |
Applicant | CIBA VISION CARE |
Date Received | 1989-08-21 |
Decision Date | 1990-03-28 |
PMA | P860060 |
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 | CIBA VISION CARE 11460 Johns Creek Pkwy. duluth, GA 30136-1518 |
Supplement Number | Date | Supplement Type |
---|---|---|
P860060 | Original Filing | |
S002 | 1989-08-21 | Normal 180 Day Track |
S001 | 1988-05-06 | Normal 180 Day Track |