FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Catheter, Percutaneous (Valvuloplasty)
PMA: P910054
·
Supplement: S006
·
Decision Sep 13, 2018
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Catheter, Percutaneous (Valvuloplasty)
- Trade Name
- Toray Inoue Balloon Catheter
- PMA Number
- P910054
- Supplement Number
- S006
- Device Class
- FDA Class 3
- Product Code
- MAD
- Generic Name
- CATHETER, PERCUTANEOUS (VALVULOPLASTY)
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- September 13, 2018
- Date Received
- September 4, 2018
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Addition of new packaging heat sealing equipment.
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 |