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PMA P130013S036

Device
WATCHMAN Left Atrial Appendage Closure Device and Delivery System, WATCHMAN Access System
Applicant
Boston Scientific Corp
PMA number
P130013
Supplement
S036
Product code
NGV
Decision date
2020-02-27
Generic name
System, appendage closure, left atrial
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.

Current openFDA PMA Record#

Device
WATCHMAN Left Atrial Appendage Closure Device and Delivery System, WATCHMAN Access System
Applicant
Boston Scientific Corp
PMA number
P130013
Supplement
S036
Product code
NGV
Generic name
System, appendage closure, left atrial
Decision date
2020-02-27
Decision code
OK30
Date received
2020-01-31
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
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.