H55 HYDROPHILIC CONTACT LENS
FDA premarket approval P890023/S002 · decided 1994-08-15
Approval details
- PMA number
- P890023
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- H55 HYDROPHILIC CONTACT LENS
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- The Cooper Companies
- Date received
- 1993-05-24
- Decision date
- 1994-08-15
- Days to decision
- 448 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.