PMA P150026S003
- Device
- HeartLight Endoscopic Ablation System
- Applicant
- Cardiofocus, Inc.
- PMA number
- P150026
- Supplement
- S003
- Product code
- OAE
- Decision date
- 2018-01-17
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Approval order statement
- Approval for an alternate sterilization process STERRAD 100NX to the current STERRAD NX process for endoscope sterilization.
Current openFDA PMA Record#
- Device
- HeartLight Endoscopic Ablation System
- Applicant
- Cardiofocus, Inc.
- PMA number
- P150026
- Supplement
- S003
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2018-01-17
- Decision code
- APPR
- Date received
- 2017-11-09
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an alternate sterilization process STERRAD 100NX to the current STERRAD NX process for endoscope sterilization.