SOFTCON(VIFILCON A) SOFT (HYDROPHILIC) CONTACT LENS(EXTENDED WEAR)
FDA premarket approval P820021/S030 · decided 2001-12-12
Approval details
- PMA number
- P820021
- Supplement
- S030
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- SOFTCON(VIFILCON A) SOFT (HYDROPHILIC) CONTACT LENS(EXTENDED WEAR)
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2001-10-16
- Decision date
- 2001-12-12
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR AN ADDITIONAL MANUFACTURING FACILITY LOCATED AT CIBA VISION CORP, CIDRA, PUERTO RICO.
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