FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter
PMA: P230035
·
Supplement: S003
·
Decision Mar 9, 2025
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter
- Trade Name
- AGENT Paclitaxel-Coated Balloon Catheter
- PMA Number
- P230035
- Supplement Number
- S003
- Device Class
- FDA Class 3
- Product Code
- OOB
- Generic Name
- Drug-eluting percutaneous transluminal coronary angioplasty catheter
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 9, 2025
- Date Received
- September 20, 2024
- Supplement Type
- 135 Review Track For 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Approval for an alternative site for analytical testing from Hemoteq to in house analytical labs.
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 |
|---|---|---|---|
| OOB | Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter | FDA class 3 | Unknown |