PMA P100010S153
- Device
- Freezor MAX 209F3,209F5
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S153
- Product code
- OAE
- Decision date
- 2026-04-23
- Classification
- Cardiovascular
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Approval order statement
- approval for Freezor Coaxial Connector Adhesive Modifications
Current openFDA PMA Record#
- Device
- Freezor MAX 209F3,209F5
- Applicant
- Medtronic Cryocath, LP
- PMA number
- P100010
- Supplement
- S153
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2026-04-23
- Decision code
- APPR
- Date received
- 2026-01-28
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for Freezor Coaxial Connector Adhesive Modifications