FDA PMA
FDA Unclassified
Approved
🇺🇸 United States
Lens, Contact (Polymethylmethacrylate)
PMA: P820063
·
Supplement: S055
·
Decision Jan 4, 1994
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Lens, Contact (Polymethylmethacrylate)
- Trade Name
- PARAPERM O2 (PASIFOCON A) RGP CONTACT LENS
- PMA Number
- P820063
- Supplement Number
- S055
- 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
- January 4, 1994
- Date Received
- November 12, 1993
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- 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 |