PMA P130013S076

Device: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY
Applicant: Boston Scientific Corp
PMA number: P130013
Supplement: S076
Product code: NGV
Decision date: 2026-03-25
Classification: Cardiovascular
Generic name: System, appendage closure, left atrial
Approval order statement: Approval of the revised protocol, including the statistical analysis plan, for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P130013/S043/A002.

Current openFDA PMA Record#

Device: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY
Applicant: Boston Scientific Corp
PMA number: P130013
Supplement: S076
Product code: NGV
Generic name: System, appendage closure, left atrial
Decision date: 2026-03-25
Decision code: APPR
Date received: 2025-02-07
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval of the revised protocol, including the statistical analysis plan, for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P130013/S043/A002.