FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Cardiac Ablation Percutaneous Catheter
PMA: P920047
·
Supplement: S137
·
Decision Aug 14, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
Research PMA P920047 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
- Cardiac Ablation Percutaneous Catheter
- Trade Name
- Blazer II Cardiac Ablation System and Cable
- PMA Number
- P920047
- Supplement Number
- S137
- Device Class
- FDA Class 3
- Product Code
- LPB
- Generic Name
- Cardiac ablation percutaneous catheter
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 14, 2025
- Date Received
- July 9, 2025
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
for a manufacturing site located at Boston Scientific de Costa Rica, S.R.L., El Coyol Alajuela, Coyol, Costa Rica (FEI: 3007695959) to perform ethylene oxide sterilization activities
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 |
|---|---|---|---|
| LPB | Cardiac Ablation Percutaneous Catheter | FDA class 3 | Unknown |