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 | DURACLEAN(TM) DAILY CLEANER |
Classification Name | Accessories, Soft Lens Products |
Generic Name | Accessories, Soft Lens Products |
Applicant | ADVANCED MEDICAL OPTICS, INC. |
Date Received | 1988-04-14 |
Decision Date | 1988-08-31 |
PMA | P870026 |
Supplement | S001 |
Product Code | LPN |
Advisory Committee | Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | ADVANCED MEDICAL OPTICS, INC. 2525 Dupont Dr. irvine, CA 92612 |
Supplement Number | Date | Supplement Type |
---|---|---|
P870026 | Original Filing | |
S007 | 1995-06-08 | Normal 180 Day Track |
S006 | 1995-05-05 | Normal 180 Day Track |
S005 | 1992-06-04 | Normal 180 Day Track |
S004 | 1990-07-25 | Normal 180 Day Track |
S003 | 1990-01-09 | Normal 180 Day Track |
S002 | 1989-09-29 | Normal 180 Day Track |
S001 | 1988-04-14 | Normal 180 Day Track |