PMA P020025S099
- Device
- Maestro 4000 Cardiac Ablation System (Controller, Remote and Pods)
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S099
- Product code
- OAD
- Decision date
- 2017-05-04
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- Alternate supplier for components used in the Maestro 4000 Cardiac Ablation System.
Current openFDA PMA Record#
- Device
- Maestro 4000 Cardiac Ablation System (Controller, Remote and Pods)
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S099
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2017-05-04
- Decision code
- OK30
- Date received
- 2017-04-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate supplier for components used in the Maestro 4000 Cardiac Ablation System.