FDA PMA
FDA Class 2
Approved
🇺🇸 United States
Lens, Contact (Other Material) - Daily
PMA: P860022
·
Supplement: S031
·
Decision Apr 16, 1991
Classifications
1
FEI Numbers
36
Registration Numbers
36
Basic Information
- Device Name
- Lens, Contact (Other Material) - Daily
- Trade Name
- BOSTON(R) RXD(TM) & ENVISION(TM) RGP CONTACT LENS
- PMA Number
- P860022
- Supplement Number
- S031
- Device Class
- FDA Class 2
- Product Code
- HQD
- Generic Name
- Lens, contact (other material) - daily
- Regulation Number
- 886.5916
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- April 16, 1991
- Date Received
- November 8, 1990
- 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 |
|---|---|---|---|
| HQD | Lens, Contact (Other Material) - Daily | FDA class 2 | Ophthalmic |