PRECISION ULTRAVIOLET (VASURFILCON A) HYDROPHILIC CONTACT LENS FOR EXTENDED WEAR
FDA premarket approval P940013/S007 · decided 2001-10-04
Approval details
- PMA number
- P940013
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- PRECISION ULTRAVIOLET (VASURFILCON A) HYDROPHILIC CONTACT LENS FOR EXTENDED WEAR
- Generic name
- Lenses, soft contact, daily wear
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2001-05-10
- Decision date
- 2001-10-04
- Days to decision
- 147 days
- Decision code
- APPR
- Product code
- LPL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR THE ALTERNATE MANUFACTURING FACILITIES LOCATED AT CIBA VISION CORPORATION, ATLANTA, GEORGIA AND CIBA VISION BATAM, BATAM ISLAND, INDONESIA.
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