PMA P060019S041
- Device
- Cool Point Tubing Set
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P060019
- Supplement
- S041
- Product code
- OAD
- Decision date
- 2017-11-02
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- Approval for a change in the size of the unit carton (outer box) for the Cool Point Tubing Set.
Current openFDA PMA Record#
- Device
- Cool Point Tubing Set
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P060019
- Supplement
- S041
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2017-11-02
- Decision code
- APPR
- Date received
- 2017-09-11
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change in the size of the unit carton (outer box) for the Cool Point Tubing Set.