|
Device | WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) DEVICE |
Generic Name | System, appendage closure, left atrial |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P130013 |
Supplement Number | S010 |
Date Received | 06/16/2016 |
Decision Date | 06/28/2016 |
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 of an alternate material and supplier for the suture component of the device. |