|
Device | WATCHMAN Left Atrial Appendage Closure Device with Delivery System |
Generic Name | System, appendage closure, left atrial |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P130013 |
Supplement Number | S039 |
Date Received | 09/30/2020 |
Decision Date | 12/16/2020 |
Product Code |
NGV |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an alternative packaging configuration change for WATCHMAN LAA Closure Device and Delivery System |