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 | SOF PRO-CLEAN CONTACT LENS CLEANER |
Generic Name | Accessories, Soft Lens Products |
Applicant | LOBOB LABORATORIES, INC. |
Date Received | 1986-04-08 |
Decision Date | 1986-06-24 |
PMA | P810041 |
Supplement | S005 |
Product Code | LPN |
Advisory Committee | Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | LOBOB LABORATORIES, INC. 1440 Atteberry Ln. san Jose, CA 95131-1410 |
Supplement Number | Date | Supplement Type |
---|---|---|
P810041 | Original Filing | |
S007 | 1990-06-13 | Normal 180 Day Track |
S006 | 1986-12-30 | Normal 180 Day Track |
S005 | 1986-04-08 | Normal 180 Day Track |
S004 | 1985-03-15 | |
S003 | 1983-12-07 | |
S002 | ||
S001 | 1982-07-08 |