- Device
- MODIFIED J & C LOOP MODEL PA36
- Applicant
- Eyekon Medical, Inc.
- PMA number
- P880072
- Supplement
- S030
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 1995-08-24
- Decision code
- APPR
- Date received
- 1995-05-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- RESPONSE TO FDA'S LETTER OF APRIL 28, 1995, RE:YOUR 1992 AND 1993 ANNUAL REPORTS & REQUESTED TIER A APPROVAL FOR MDLS:GL55A-OUV, GL55B-OUV,PS40D-OUV,PS60C-OUV,PB61B-OUV,PB07C-OUV & LP57L-OUV ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER IOLS