FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Catheter, Coronary, Atherectomy
PMA: P130005
·
Supplement: S049
·
Decision Feb 18, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
Research PMA P130005 in seconds
The Research Assistant summarizes PMA approval history, supplements and related safety signals — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Catheter, Coronary, Atherectomy
- Trade Name
- DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
- PMA Number
- P130005
- Supplement Number
- S049
- Device Class
- FDA Class 3
- Product Code
- MCX
- Generic Name
- CATHETER, CORONARY, ATHERECTOMY
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- February 18, 2026
- Date Received
- January 22, 2026
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
implementing duplicate overmold equipment and updating the equipment parameters for the Diamondback 360 and Diamondback 360 Precision Coronary Orbital Atherectomy Device (OAD)
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 |