FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
Catheter, Coronary, Atherectomy
PMA: P910019
·
Decision May 18, 1993
Classifications
1
FEI Numbers
22
Registration Numbers
22
Basic Information
- Device Name
- Catheter, Coronary, Atherectomy
- Trade Name
- IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)
- PMA Number
- P910019
- Device Class
- FDA Class 3
- Product Code
- MCX
- Generic Name
- CATHETER, CORONARY, ATHERECTOMY
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- May 18, 1993
- Date Received
- March 29, 1991
- Expedited Review
- N
- Docket Number
- 93M-0209
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 |
|---|---|---|---|
| MCX | Catheter, Coronary, Atherectomy | FDA class 3 | Unknown |