PMA P990013S029
- Device
- COLLAMER UV-ABSORBING POSTERIOR CHAMBER IOL
- Applicant
- Starr Surgical Co.
- PMA number
- P990013
- Supplement
- S029
- Product code
- HQL
- Decision date
- 2010-09-16
- Classification
- Intraocular Lens
- Generic name
- intraocular lens
- Approval order statement
- APPROVAL FOR MODIFICATION TO THE DIRECTIONS FOR USE TO COMPLY WITH THE LATEST MEDICAL DEVICE DIRECTIVE (MDD) 93/42/EEC.
Current openFDA PMA Record#
- Device
- COLLAMER UV-ABSORBING POSTERIOR CHAMBER IOL
- Applicant
- Starr Surgical Co.
- PMA number
- P990013
- Supplement
- S029
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2010-09-16
- Decision code
- APPR
- Date received
- 2010-08-17
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MODIFICATION TO THE DIRECTIONS FOR USE TO COMPLY WITH THE LATEST MEDICAL DEVICE DIRECTIVE (MDD) 93/42/EEC.