PMA P110042S171

Device: SICD Gen 2 A209, SICD MRI A219
Applicant: Boston Scientific Corporation
PMA number: P110042
Supplement: S171
Product code: LWS
Decision date: 2022-07-13
Generic name: Implantable cardioverter defibrillator (non-CRT)
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: SICD Gen 2 A209, SICD MRI A219
Applicant: Boston Scientific Corporation
PMA number: P110042
Supplement: S171
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
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.