METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR
FDA premarket approval P850079/S041 · decided 2003-02-12
Approval details
- PMA number
- P850079
- Supplement
- S041
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2002-08-20
- Decision date
- 2003-02-12
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
- Statement
- APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT COOPERVISION, INC., NORFOLK, VIRGINIA.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.