FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
Lenses, Soft Contact, Extended Wear
PMA: P850077
·
Decision Jan 31, 1986
Classifications
1
FEI Numbers
56
Registration Numbers
56
Basic Information
- Device Name
- Lenses, Soft Contact, Extended Wear
- Trade Name
- SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS
- PMA Number
- P850077
- Device Class
- FDA Class 3
- Product Code
- LPM
- Generic Name
- Lenses, soft contact, extended wear
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- January 31, 1986
- Date Received
- October 30, 1985
- Expedited Review
- N
- Docket Number
- 86M-0108
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LPM | Lenses, Soft Contact, Extended Wear | FDA class 3 | Ophthalmic |