WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System, WATCHMAN Left Atrial Appendage (LAA) Closure Te
FDA premarket approval P130013/S050 · decided 2022-10-17
Approval details
- PMA number
- P130013
- Supplement
- S050
- 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 Left Atrial Appendage (LAA) Closure Te
- Generic name
- System, appendage closure, left atrial
- Applicant
- Boston Scientific Corp
- Date received
- 2022-07-19
- Decision date
- 2022-10-17
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- NGV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for design and manufacturing changes including the addition of stabilizers to the delivery sheath material formulation, a new in-house supplier for the delivery sheath, and the addition of a liner at the end of the sheath braid to facilitate tacking.
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