FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Lenses, Soft Contact, Extended Wear
PMA: P830047
·
Supplement: S005
·
Decision Nov 14, 1990
Classifications
1
FEI Numbers
56
Registration Numbers
56
Basic Information
- Device Name
- Lenses, Soft Contact, Extended Wear
- Trade Name
- M-70 (LIDOFILCON A) HYDROPHILIC CONTACT LENS
- PMA Number
- P830047
- Supplement Number
- S005
- 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
- Decision Code
- APPR
- Decision Date
- November 14, 1990
- Date Received
- May 2, 1990
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
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 |