|
Device | WATCHMAN Left Atrial Appendage Closure 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 | S033 |
Date Received | 07/23/2019 |
Decision Date | 10/18/2019 |
Product Code |
NGV |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to update the clinical data in the directions for use with the currently available data and make minor changes to the language in the directions for use and patient brochure. |