DiamondTemp Ablation System with the EnSite X Mapping System
FDA premarket approval P200028/S012 · decided 2022-10-12
Approval details
- PMA number
- P200028
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DiamondTemp Ablation System with the EnSite X Mapping System
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Applicant
- Medtronic, Inc.
- Date received
- 2022-07-15
- Decision date
- 2022-10-12
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- OAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for compatibility of the DiamondTemp Ablation System with the Abbott EnSite X mapping and navigation system.
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