WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System
FDA premarket approval P130013/S052 · decided 2023-05-11
Approval details
- PMA number
- P130013
- Supplement
- S052
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System
- Generic name
- System, appendage closure, left atrial
- Applicant
- Boston Scientific Corp
- Date received
- 2022-09-28
- Decision date
- 2023-05-11
- Days to decision
- 225 days
- Decision code
- APPR
- Product code
- NGV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval to add an alternative imaging modality option, intracardiac echocardiography (ICE), to the Instructions for Use (IFU) for use during the implant procedure. Additionally, you proposed updating the IFU with new clinical data, updating the Indications for Use to align with current practice, as well as streamline the IFU, Pouch Label, Spine Label, Carton Label, Patient Guide and Patient Implant Card in accordance with current labeling procedures.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) (K243245) | Boston Scientific Corp | 2024-10-18 |
| LUX-Dx II (M302); LUX-Dx II+ (M312) (K231328) | Boston Scientific Corp | 2023-08-19 |
| WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary (K152853) | Boston Scientific Corp | 2015-11-20 |
| AXIOS Stent with Electrocautery Enhanced Delivery System (K150692) | Boston Scientific Corp | 2015-08-05 |
| XXL Vascular Balloon Dilatation Catheter (K150303) | Boston Scientific Corp | 2015-06-15 |
| Chariot Guiding Sheath (K150186) | Boston Scientific Corp | 2015-06-05 |
| EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679) | Boston Scientific Corp | 2015-05-29 |
| JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820) | Boston Scientific Corp | 2014-10-21 |