PMA P150026S010
- Device
- HeartLight System
- Applicant
- Cardiofocus, Inc.
- PMA number
- P150026
- Supplement
- S010
- Product code
- OAE
- Decision date
- 2020-02-20
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Approval order statement
- Implementation of a revised Nosecone Forming Fixture used in manufacturing of the HeartLight® family of Catheters.
Current openFDA PMA Record#
- Device
- HeartLight System
- Applicant
- Cardiofocus, Inc.
- PMA number
- P150026
- Supplement
- S010
- Product code
- OAE
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Decision date
- 2020-02-20
- Decision code
- OK30
- Date received
- 2020-01-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of a revised Nosecone Forming Fixture used in manufacturing of the HeartLight® family of Catheters.