ETAFILCON HYDROPHILIC CONTACT LENSES
FDA premarket approval N18033/S036 · decided 2001-07-30
Approval details
- PMA number
- N18033
- Supplement
- S036
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ETAFILCON HYDROPHILIC CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Johnson & Johnson Vision Products, Inc.
- Date received
- 2001-06-29
- Decision date
- 2001-07-30
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- APPROVAL FOR AN ALTERNATE PACKAGE INTEGRITY TEST METHOD TO SUPPORT SHELF-LIFE AND ASSIGN EXPIRATION DATES IN LIEU OF STERILITY TESTING.
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