INTELLAGEN Cardiac Ablation System
FDA premarket approval P020025/S141 · decided 2024-07-17
Approval details
- PMA number
- P020025
- Supplement
- S141
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INTELLAGEN Cardiac Ablation System
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2023-07-14
- Decision date
- 2024-07-17
- Days to decision
- 369 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- an alternate and compatible radiofrequency (RF) generator, remote control, irrigation pump, tubing set, and foot pedal referred to collectively as the INTELLAGEN Cardiac Ablation System (INTELLAGEN)
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