FDA.reportPublic FDA data

PMA P010012S515

Device
ICD ORIGEN CRT-D DF4/IS1, DF/IS1/ DF1/IS1/IS4, AND DF4/IS1/IS4, MMENTUM CRT-D IS1 DF4 IS1
Applicant
Boston Scientific Corp
PMA number
P010012
Supplement
S515
Product code
NIK
Decision date
2020-01-28
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
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
ICD ORIGEN CRT-D DF4/IS1, DF/IS1/ DF1/IS1/IS4, AND DF4/IS1/IS4, MMENTUM CRT-D IS1 DF4 IS1
Applicant
Boston Scientific Corp
PMA number
P010012
Supplement
S515
Product code
NIK
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
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.