PMA P240013S029
- Device
- Sphere-9 Catheter and Affera Ablation System
- Applicant
- Medtronic, Inc.
- PMA number
- P240013
- Supplement
- S029
- Product code
- QZI
- Decision date
- 2026-08-04
- Classification
- Cardiovascular
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Approval order statement
- to duplicate a manufacturing location for an existing supplier
Current openFDA PMA Record#
- Device
- Sphere-9 Catheter and Affera Ablation System
- Applicant
- Medtronic, Inc.
- PMA number
- P240013
- Supplement
- S029
- Product code
- QZI
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Decision date
- 2026-08-04
- Decision code
- OK30
- Date received
- 2026-07-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to duplicate a manufacturing location for an existing supplier