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 | NOR-SA-TAB |
Generic Name | Accessories, Soft Lens Products |
Applicant | AMCON, INC. |
Date Received | 1986-06-18 |
Decision Date | 1986-12-04 |
PMA | P800069 |
Supplement | S008 |
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 | AMCON, INC. 1102 Main St. p.o. Box 176 grandview, MO 64030 |
Supplement Number | Date | Supplement Type |
---|---|---|
P800069 | Original Filing | |
S009 | 1987-11-24 | Special (immediate Track) |
S008 | 1986-06-18 | Normal 180 Day Track |
S007 | 1985-05-24 | |
S006 | 1985-04-16 | |
S005 | ||
S004 | 1982-05-12 | |
S003 | 1982-05-12 | |
S002 | 1982-05-12 | |
S001 | 1982-01-15 |