FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Catheter, Percutaneous (Valvuloplasty)
PMA: P910054
·
Supplement: S001
·
Decision Nov 30, 1995
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Catheter, Percutaneous (Valvuloplasty)
- Trade Name
- INOUE BALLOON CATHETER
- PMA Number
- P910054
- Supplement Number
- S001
- Device Class
- FDA Class 3
- Product Code
- MAD
- Generic Name
- CATHETER, PERCUTANEOUS (VALVULOPLASTY)
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 30, 1995
- Date Received
- May 22, 1995
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A MODIFICATION OF THE STERILIZATION CYCLE
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 |
|---|---|---|---|
| MAD | Catheter, Percutaneous (Valvuloplasty) | FDA class 3 | Unknown |