FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Catheter, Coronary, Atherectomy
PMA: P130005
·
Supplement: S048
·
Decision Jan 14, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Catheter, Coronary, Atherectomy
- Trade Name
- Diamondback 360 Coronary Orbital Atherectomy System; Diamondback 360 Precision Coronary Orbital Atherectomy System
- PMA Number
- P130005
- Supplement Number
- S048
- Device Class
- FDA Class 3
- Product Code
- MCX
- Generic Name
- CATHETER, CORONARY, ATHERECTOMY
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- January 14, 2026
- Date Received
- December 15, 2025
- Supplement Type
- Special (Immediate Track)
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
labeling updates to add IEC 60601 electrical safety warnings to the electronic Instructions for Use
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 |