FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Implant, Corneal, Refractive
PMA: P980031
·
Supplement: S006
·
Decision Nov 5, 2003
Classifications
1
FEI Numbers
3
Registration Numbers
3
Basic Information
- Device Name
- Implant, Corneal, Refractive
- Trade Name
- INTACS PRESCRIPTION INSERTS
- PMA Number
- P980031
- Supplement Number
- S006
- Device Class
- FDA Class 3
- Product Code
- LQE
- Generic Name
- Implant, corneal, refractive
- Medical Specialty
- Unknown
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 5, 2003
- Date Received
- May 14, 2003
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A MANUFACTURING SITE IN SUNNYVALE, CALIFORNIA.
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 |
|---|---|---|---|
| LQE | Implant, Corneal, Refractive | FDA class 3 | Unknown |