PERMALENS (PERFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES
FDA premarket approval P780010/S022 · decided 2001-11-16
Approval details
- PMA number
- P780010
- Supplement
- S022
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- PERMALENS (PERFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2001-04-18
- Decision date
- 2001-11-16
- Days to decision
- 212 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR A CHANGE IN INITIATOR FOR THE REFERENCED DEVICES MANUFACTURED AT AN ALTERNATE MANUFACTURING SITE LOCATED IN COOPERVISION, HUNTINGTON BEACH, CALIFORNIA.
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