FDA.reportPublic FDA data

PMA P960040S447

Device
ICE ORIGEN VR DF4, VR DF1/IS1, DR DF4/IS1, DR DF1/IS1, ICD INOGEN VR DF4, VR DF1/IS1, DR DF4/IS1, DR DF1/IS1, ICD DYNAGE
Applicant
Boston Scientific
PMA number
P960040
Supplement
S447
Product code
LWS
Decision date
2020-01-28
Generic name
Implantable cardioverter defibrillator (non-CRT)
Approval order statement
Reduce the burn-in process temperature setting used during manufacturing of the Integrated Circuit modules of the NG3/NG4 and Accolade Pulse Generator product families.

Current openFDA PMA Record#

Device
ICE ORIGEN VR DF4, VR DF1/IS1, DR DF4/IS1, DR DF1/IS1, ICD INOGEN VR DF4, VR DF1/IS1, DR DF4/IS1, DR DF1/IS1, ICD DYNAGE
Applicant
Boston Scientific
PMA number
P960040
Supplement
S447
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2020-01-28
Decision code
OK30
Date received
2020-01-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Reduce the burn-in process temperature setting used during manufacturing of the Integrated Circuit modules of the NG3/NG4 and Accolade Pulse Generator product families.