PMA P060019S038
- Device
- Therapy Cool Path Ablation Catheters
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P060019
- Supplement
- S038
- Product code
- OAD
- Decision date
- 2016-09-08
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- Changes to the environmental specifications and installation of data loggers for environmental monitoring.
Current openFDA PMA Record#
- Device
- Therapy Cool Path Ablation Catheters
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P060019
- Supplement
- S038
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2016-09-08
- Decision code
- OK30
- Date received
- 2016-08-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the environmental specifications and installation of data loggers for environmental monitoring.