COPPERVISION METHAFILCON AB SOFT EXTENDED WEAR CONTACT LENSES
FDA premarket approval P850079/S055 · decided 2012-09-18
Approval details
- PMA number
- P850079
- Supplement
- S055
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COPPERVISION METHAFILCON AB SOFT EXTENDED WEAR CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2012-08-20
- Decision date
- 2012-09-18
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
- Statement
- TEMPORARY CHANGE TO THE INSPECTION PROCESS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.