WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System
FDA premarket approval P130013/S026 · decided 2019-02-20
Approval details
- PMA number
- P130013
- Supplement
- S026
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System
- Generic name
- System, appendage closure, left atrial
- Applicant
- Boston Scientific Corp
- Date received
- 2019-01-22
- Decision date
- 2019-02-20
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NGV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Alternate visual inspection tool for the frame.
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510(k) clearances by this applicant
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