POSTERIOR CHAMBER INTRAOCULAR LENSES
FDA premarket approval P970034/S008 · decided 2001-12-31
Approval details
- PMA number
- P970034
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- POSTERIOR CHAMBER INTRAOCULAR LENSES
- Generic name
- intraocular lens
- Applicant
- Aaren Scientific
- Date received
- 2001-03-26
- Decision date
- 2001-12-31
- Days to decision
- 280 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Ontario, CA
- Statement
- APPROVAL FOR MODEL UB55AC POSTERIOR CHAMBER INTRAOCULAR 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.