WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Closure
FDA premarket approval P130013/S086 · decided 2026-07-21
Approval details
- PMA number
- P130013
- Supplement
- S086
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Closure
- Generic name
- System, appendage closure, left atrial
- Applicant
- Boston Scientific Corp
- Date received
- 2026-04-21
- Decision date
- 2026-07-21
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- NGV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for a Delivery Sheath print update to allow for acceptance of a defined number of broken braid wires for the continuous braiding method for WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System and WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System
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510(k) clearances by this applicant
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|---|---|---|
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| 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 |