HeartLight® X3 Catheter with Excalibur Balloon
FDA premarket approval P150026/S013 · decided 2022-04-02
Approval details
- PMA number
- P150026
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HeartLight® X3 Catheter with Excalibur Balloon
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Applicant
- Cardiofocus, Inc.
- Date received
- 2022-03-04
- Decision date
- 2022-04-02
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- OAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Marlborough, MA
- Statement
- Approval for a manufacturing site located at Sterigenics, Inc., 84 Park Road, Queensbury, NY 12804 as an alternate sterilization site for the HeartLight X3 Catheter with Excalibur Balloon.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |