|
Device | WATCHMAN LAA CLOSURE TECHNOLOGY |
Generic Name | System, appendage closure, left atrial |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P130013 |
Supplement Number | S005 |
Date Received | 08/21/2015 |
Decision Date | 09/02/2015 |
Product Code |
NGV |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE LABELING TO CLARIFY USE OF THE HEMOSTASIS VALVE ON THE WATCHMAN ACCESS SYSTEM. |