PMA P970034S009
- Device
- POSTERIOR CHAMBER IOL'S
- Applicant
- Aaren Scientific
- PMA number
- P970034
- Supplement
- S009
- Product code
- HQL
- Decision date
- 2001-06-29
- Classification
- Intraocular Lens
- Generic name
- intraocular lens
- Approval order statement
- APPROVAL FOR OPHTHALMIC INNOVATIONS INTERNATIONAL, INC. TO PRIVATE-LABEL ITS PMA-APPROVED POSTERIOR-CHAMBER INTRAOCULAR LENSES FOR DISTRIBUTION IN THE UNITED STATES BY CIBA VISION CORPORATION. THE DEVICES AS MODIFIED WILL BE MARKETED UNDER THE TRADE-NAMES, CIBA VISION INTRAOCULAR LENS MODELS 0420F, 0455F, 0440U, 0840U, 0430M, 0840Z2, AND 0840Z, AND ARE INDICATED FOR THE VISUAL CORRECTION OF APHAKIA IN PERSONS 60 YEARS OF AGE OR OLDER, WHO ARE UNDERGOING EXTRACAPSULAR EXTRACTION AND PRIMARY LENS IMPLANTATION.
Current openFDA PMA Record#
- Device
- POSTERIOR CHAMBER IOL'S
- Applicant
- Aaren Scientific
- PMA number
- P970034
- Supplement
- S009
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2001-06-29
- Decision code
- APPR
- Date received
- 2001-04-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Approval order statement
- APPROVAL FOR OPHTHALMIC INNOVATIONS INTERNATIONAL, INC. TO PRIVATE-LABEL ITS PMA-APPROVED POSTERIOR-CHAMBER INTRAOCULAR LENSES FOR DISTRIBUTION IN THE UNITED STATES BY CIBA VISION CORPORATION. THE DEVICES AS MODIFIED WILL BE MARKETED UNDER THE TRADE-NAMES, CIBA VISION INTRAOCULAR LENS MODELS 0420F, 0455F, 0440U, 0840U, 0430M, 0840Z2, AND 0840Z, AND ARE INDICATED FOR THE VISUAL CORRECTION OF APHAKIA IN PERSONS 60 YEARS OF AGE OR OLDER, WHO ARE UNDERGOING EXTRACAPSULAR EXTRACTION AND PRIMARY LENS IMPLANTATION.