PMA P010012S555

Device: ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, VIGILANT CRT-D, VIGILANT X4 CR
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S555
Product code: NIK
Decision date: 2022-07-13
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: Addition of Ansell nitrile gloves as an alternative glove for use during cardiac rhythm management (CRM) pulse generator manufacturing at the St. Paul site.

Current openFDA PMA Record#

Device: ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, VIGILANT CRT-D, VIGILANT X4 CR
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S555
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2022-07-13
Decision code: OK30
Date received: 2022-06-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of Ansell nitrile gloves as an alternative glove for use during cardiac rhythm management (CRM) pulse generator manufacturing at the St. Paul site.