POSTERIOR CHAMBER IOL'S
FDA premarket approval P970034/S009 · decided 2001-06-29
Approval details
- PMA number
- P970034
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- POSTERIOR CHAMBER IOL'S
- Generic name
- intraocular lens
- Applicant
- Aaren Scientific
- Date received
- 2001-04-19
- Decision date
- 2001-06-29
- Days to decision
- 71 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Ontario, CA
- 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
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.