FRESHLOOK(TM) UV SPHERICAL (PHEMFILCON A) MOLDED SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR
FDA premarket approval P830037/S043 · decided 2000-11-09
Approval details
- PMA number
- P830037
- Supplement
- S043
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FRESHLOOK(TM) UV SPHERICAL (PHEMFILCON A) MOLDED SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2000-10-10
- Decision date
- 2000-11-09
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT WESLEY JESSEN PBH LIMITED, SOUTHAMPTON, UNITED KINGDOM.
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