PERMALENS EXTENDED WEAR CONTACT LENS
FDA premarket approval P780010/S019 · decided 1992-02-25
Approval details
- PMA number
- P780010
- Supplement
- S019
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PERMALENS EXTENDED WEAR CONTACT LENS
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 1991-12-05
- Decision date
- 1992-02-25
- Days to decision
- 82 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.