METHAFILCON A SOFT HYDROPHILIC SPERICAL/TORIC CONTACT LENSES
FDA premarket approval P850079/S032 · decided 1999-11-24
Approval details
- PMA number
- P850079
- Supplement
- S032
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- METHAFILCON A SOFT HYDROPHILIC SPERICAL/TORIC CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 1999-09-28
- Decision date
- 1999-11-24
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
- Statement
- Approval for adding disposable and frequent/planned replacement to the wearing schedule.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.