Heart Light Catheter with Excalibur Balloon
FDA premarket approval P150026/S002 · decided 2018-05-02
Approval details
- PMA number
- P150026
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Heart Light Catheter with Excalibur Balloon
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Applicant
- Cardiofocus, Inc.
- Date received
- 2017-08-09
- Decision date
- 2018-05-02
- Days to decision
- 266 days
- Decision code
- APPR
- Product code
- OAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Marlborough, MA
- Statement
- Approval for the HeartLight Endoscopic Ablation System with Excalibur Balloon, which represents design and labeling changes to the HeartLight Endoscopic Ablation System, including changes to the balloon component and cooling loop, and the addition of a balloon remote.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| HeartLight Deflectable Sheath (K152310) | Cardiofocus, Inc. | 2016-02-24 |
| CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR (K013201) | Cardiofocus, Inc. | 2002-03-18 |
| MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM) (K013901) | Cardiofocus, Inc. | 2001-12-20 |
| SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C (K011988) | Cardiofocus, Inc. | 2001-09-20 |
| SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C (K993834) | Cardiofocus, Inc. | 2000-02-04 |