METHAFILCON A
FDA premarket approval P850079/S036 · decided 2000-03-23
Approval details
- PMA number
- P850079
- Supplement
- S036
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- METHAFILCON A
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2000-03-06
- Decision date
- 2000-03-23
- Days to decision
- 17 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
- Statement
- Introduction of an alternate manufacturing process for the extended wear contact lens.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.