PMA P200028S011
- Device
- DiamondTemp Ablation Catheters
- Applicant
- Medtronic, Inc.
- PMA number
- P200028
- Supplement
- S011
- Product code
- OAE
- Decision date
- 2022-06-15
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Approval order statement
- Changes to electrical tests for the DiamondTemp Ablation Catheters.
Current openFDA PMA Record#
- Device
- DiamondTemp Ablation Catheters
- Applicant
- Medtronic, Inc.
- PMA number
- P200028
- Supplement
- S011
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2022-06-15
- Decision code
- OK30
- Date received
- 2022-05-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to electrical tests for the DiamondTemp Ablation Catheters.