PMA P060019
- Device
- Cool Point™ Tubing Set
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P060019
- Supplement
- S054
- Product code
- OAD
- Decision date
- 2025-12-19
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- changes in polycarbonate resins, adhesives, and luers with minor dimensional changes
Current openFDA PMA Record#
- Device
- Cool Point™ Tubing Set
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P060019
- Supplement
- S058
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2025-12-19
- Decision code
- OK30
- Date received
- 2025-12-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes in polycarbonate resins, adhesives, and luers with minor dimensional changes