Watchman Left Atrial Appendage Closure Technology
FDA premarket approval P130013/S019 · decided 2018-05-18
Approval details
- PMA number
- P130013
- Supplement
- S019
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Watchman Left Atrial Appendage Closure Technology
- Generic name
- System, appendage closure, left atrial
- Applicant
- Boston Scientific Corp
- Date received
- 2018-02-21
- Decision date
- 2018-05-18
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- NGV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for changes to the hub cap component of the WATCHMAN access system.
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|---|---|---|
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