- Device
- PERMALENS (PERFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES
- Applicant
- CooperVision, Inc.
- PMA number
- P780010
- Supplement
- S022
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2001-11-16
- Decision code
- APPR
- Date received
- 2001-04-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Approval order statement
- APPROVAL FOR A CHANGE IN INITIATOR FOR THE REFERENCED DEVICES MANUFACTURED AT AN ALTERNATE MANUFACTURING SITE LOCATED IN COOPERVISION, HUNTINGTON BEACH, CALIFORNIA.