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 | KESTREL NO. 695 HEATER |
Generic Name | Accessories, Soft Lens Products |
Applicant | ATRION MEDICAL PRODUCTS, INC. |
Date Received | 1983-11-08 |
Decision Date | 1985-02-08 |
PMA | P820087 |
Supplement | S002 |
Product Code | LPN |
Advisory Committee | Ophthalmic |
Expedited Review | No |
Combination Product | No |
Applicant Address | ATRION MEDICAL PRODUCTS, INC. 1426 Curt Francis Rd. arab, AL 35016 |
Supplement Number | Date | Supplement Type |
---|---|---|
P820087 | Original Filing | |
S011 | 1987-12-22 | Normal 180 Day Track |
S010 | 1987-07-30 | Normal 180 Day Track |
S009 | 1987-07-13 | Normal 180 Day Track |
S008 | 1987-05-04 | Normal 180 Day Track |
S007 | 1987-03-10 | Normal 180 Day Track |
S006 | 1986-03-04 | |
S005 | 1986-03-04 | |
S004 | 1985-04-16 | |
S003 | 1985-04-16 | |
S002 | 1983-11-08 | |
S001 | 1983-11-08 |