WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX Left Atrial Appendage Closure D
FDA premarket approval P130013/S081 · decided 2025-11-06
Approval details
- PMA number
- P130013
- Supplement
- S081
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX Left Atrial Appendage Closure D
- Generic name
- System, appendage closure, left atrial
- Applicant
- Boston Scientific Corp
- Date received
- 2025-10-10
- Decision date
- 2025-11-06
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- NGV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for additional warnings and instructions in to the WATCHMAN FLX and WATCHMAN FLX Pro System's Instructions for Use (IFU) to reduce the risk of air embolism during use.
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