HeartLight Endoscopic Ablation System
FDA premarket approval P150026/S006 · decided 2019-06-24
Approval details
- PMA number
- P150026
- Supplement
- S006
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HeartLight Endoscopic Ablation System
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Applicant
- Cardiofocus, Inc.
- Date received
- 2019-05-29
- Decision date
- 2019-06-24
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- OAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Marlborough, MA
- Statement
- Approval for a labeling change to add a contraindication.
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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 |