DiamondTemp Unidirectional Ablation Catheter, Small Curve, DiamondTemp Unidirectional Ablation Catheter, Large Curve,
FDA premarket approval P200028/S020 · decided 2023-07-21
Approval details
- PMA number
- P200028
- Supplement
- S020
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DiamondTemp Unidirectional Ablation Catheter, Small Curve, DiamondTemp Unidirectional Ablation Catheter, Large Curve,
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Applicant
- Medtronic, Inc.
- Date received
- 2023-06-07
- Decision date
- 2023-07-21
- Days to decision
- 44 days
- Decision code
- APPR
- Product code
- OAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for a manufacturing site located at Medtronic Ireland, Parkmore Business Park West, Galway, Ireland (FEI: 3002806434).
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