|
Device | WATCHMAN Left Atrial Appendage 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 | S013 |
Date Received | 03/17/2017 |
Decision Date | 04/13/2017 |
Product Code |
NGV |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Use of alternate Biological Indicators (BIs) used for routine monitoring of EO sterilization. |