FDA PMA
FDA Unclassified
Approved
🇺🇸 United States
Lens, Contact (Polymethylmethacrylate)
PMA: P850068
·
Supplement: S003
·
Decision Feb 10, 1989
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Lens, Contact (Polymethylmethacrylate)
- Trade Name
- SILSOFT (ELASTOFILCON A) CONTACT LENSES
- PMA Number
- P850068
- Supplement Number
- S003
- 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
- February 10, 1989
- Date Received
- July 22, 1988
- Supplement Type
- Special (Immediate Track)
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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 |