VISTAKON (ETAFILICON A) ACUVUE(R),SUREVUE(R) LENS
FDA premarket approval N18033/S028 · decided 1996-03-05
Approval details
- PMA number
- N18033
- Supplement
- S028
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VISTAKON (ETAFILICON A) ACUVUE(R),SUREVUE(R) LENS
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Johnson & Johnson Vision Products, Inc.
- Date received
- 1996-02-06
- Decision date
- 1996-03-05
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- APPROVAL FOR UTILIZING AN ALTERNATE PROTOCOL FOR ESTABLISHING SHELF-LIFE STABILITY
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