DiamondTemp Catheter, Unidirectional, Small Curve, DiamondTemp Catheter, Unidirectional, Large Curve, DiamondTemp Cathet
FDA premarket approval P200028/S022 · decided 2023-10-12
Approval details
- PMA number
- P200028
- Supplement
- S022
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DiamondTemp Catheter, Unidirectional, Small Curve, DiamondTemp Catheter, Unidirectional, Large Curve, DiamondTemp Cathet
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Applicant
- Medtronic, Inc.
- Date received
- 2023-09-28
- Decision date
- 2023-10-12
- Days to decision
- 14 days
- Decision code
- OK30
- Product code
- OAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- removal of operators hands/gloves testing from the environmental monitoring program for all devices, manufactured at Medtronic Ireland in controlled environment areas meeting ISO Class 8 requirements
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510(k) clearances by this applicant
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