FDA.reportPublic FDA data

PMA P960040S455

Device
ICD AUTOGEN DR, ICD AUTOGEN VR, ICD DYNAGEN DR, ICD DYNAGEN VR, ICD INOGEN DR, ICD INOGEN VR, ICD ORIGEN DR, ICD ORIGEN
Applicant
Boston Scientific
PMA number
P960040
Supplement
S455
Product code
LWS
Decision date
2020-10-22
Generic name
Implantable cardioverter defibrillator (non-CRT)
Approval order statement
Change the inspection criteria, cycle duration, brush life, and gowning requirements for the automated de-burring process of pulse generator case halves.

Current openFDA PMA Record#

Device
ICD AUTOGEN DR, ICD AUTOGEN VR, ICD DYNAGEN DR, ICD DYNAGEN VR, ICD INOGEN DR, ICD INOGEN VR, ICD ORIGEN DR, ICD ORIGEN
Applicant
Boston Scientific
PMA number
P960040
Supplement
S455
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2020-10-22
Decision code
OK30
Date received
2020-10-01
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change the inspection criteria, cycle duration, brush life, and gowning requirements for the automated de-burring process of pulse generator case halves.