PMA P150026S011
- Device
- HeartLight Catheter and HeartLight Console
- Applicant
- Cardiofocus, Inc.
- PMA number
- P150026
- Supplement
- S011
- Product code
- OAE
- Decision date
- 2020-07-01
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- HeartLight Catheter and HeartLight Console
- Applicant
- Cardiofocus, Inc.
- PMA number
- P150026
- Supplement
- S011
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2020-07-01
- Decision code
- APPR
- Date received
- 2020-06-01
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.