FDA PMA
FDA Unclassified
Approved
🇺🇸 United States
Lens, Contact (Polymethylmethacrylate)
PMA: P850008
·
Supplement: S001
·
Decision Dec 1, 1986
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Lens, Contact (Polymethylmethacrylate)
- Trade Name
- THE BOSTON LENS II ALGES(R) BIFOCAL CONTACT LENS
- PMA Number
- P850008
- Supplement Number
- S001
- Device Class
- FDA Unclassified
- Product Code
- HPX
- Generic Name
- Lens, contact (polymethylmethacrylate)
- Medical Specialty
- Unknown
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- December 1, 1986
- Date Received
- August 14, 1986
- 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 |
|---|---|---|---|
| HPX | Lens, Contact (Polymethylmethacrylate) | FDA unclassified | Unknown |