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 | 1987-07-13 |
| Decision Date | 1988-01-19 |
| PMA | P820087 |
| Supplement | S009 |
| 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 | 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 |