|
Device | WATCHMAN Left Atrial Appendage Closure Device and Delivery System, WATCHMAN Access System |
Generic Name | System, appendage closure, left atrial |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P130013 |
Supplement Number | S036 |
Date Received | 01/31/2020 |
Decision Date | 02/27/2020 |
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 Reduce ethylene oxide sterilization concentrations and increase maximum density for a sterilization load at specified cycles/chambers in Steris Tullamore and Steris Minnesota. |