HEMA FOR VISTAKON (ETAFILCON A) SOFT HYDROPHILIC CONTACT LENSES
FDA premarket approval N18033/S041 · decided 2009-05-20
Approval details
- PMA number
- N18033
- Supplement
- S041
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HEMA FOR VISTAKON (ETAFILCON A) SOFT HYDROPHILIC CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Vistakon, Johnson & Johnson Vision Products, Inc.
- Date received
- 2009-04-20
- Decision date
- 2009-05-20
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- CHANGE TO IMPLEMENT AN ALTERNATE SUPPLIER FOR THE CRITICAL MATERIAL, HEMA, USED IN THE PRODUCTION OF THE DEVICE.
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