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 | STERIDYNE DYNASPRAY |
Generic Name | Accessories, Soft Lens Products |
Applicant | OPTOPICS LABORATORIES CORP. |
Date Received | 1988-07-25 |
Decision Date | 1989-01-05 |
PMA | P860050 |
Supplement | S006 |
Product Code | LPN |
Advisory Committee | Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/components/specifications/material |
Expedited Review | No |
Combination Product | No |
Applicant Address | OPTOPICS LABORATORIES CORP. p.o. Box 210 fairton, NJ 08320-0210 |
Supplement Number | Date | Supplement Type |
---|---|---|
P860050 | Original Filing | |
S007 | 1990-01-26 | Normal 180 Day Track |
S006 | 1988-07-25 | Normal 180 Day Track |
S005 | 1987-12-14 | Normal 180 Day Track |
S004 | ||
S003 | ||
S002 | 1987-03-30 | Normal 180 Day Track |
S001 | 1987-05-21 | Normal 180 Day Track |