|
Device | WATCHMAN LEFT ATRIAL APPENDAGE (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 | S001 |
Date Received | 04/10/2015 |
Decision Date | 11/21/2016 |
Product Code |
NGV |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to modify the post-approval study (PAS) condition of approval. |