HeartLight Catheter, HeartLight X3 Console V2
FDA premarket approval P150026/S015 · decided 2023-08-11
Approval details
- PMA number
- P150026
- Supplement
- S015
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HeartLight Catheter, HeartLight X3 Console V2
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Applicant
- Cardiofocus, Inc.
- Date received
- 2023-03-02
- Decision date
- 2023-08-11
- Days to decision
- 162 days
- Decision code
- APPR
- Product code
- OAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Marlborough, MA
- Statement
- Approval for the transition of the Console manufacturing from the current contractor, Minnetronix, 1635 Energy Park Dr, St Paul, MN 55108 USA to Gener8, 2560 Junction Ave., San Jose CA 95134 USA.
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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 |