PMA N970003S273

Device: PG ESSENTIO SR, PG ESSENTIO DR, PG PROPONENT SR, PG PROPONENT DR, PG ACCOLADE SR, PG ACCOLADE DR, PG ALTRUA 2 SR, PG ALT
Applicant: Boston Scientific Corp
PMA number: N970003
Supplement: S273
Product code: LWP
Decision date: 2022-07-13
Generic name: Implantable pulse generator, pacemaker (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: PG ESSENTIO SR, PG ESSENTIO DR, PG PROPONENT SR, PG PROPONENT DR, PG ACCOLADE SR, PG ACCOLADE DR, PG ALTRUA 2 SR, PG ALT
Applicant: Boston Scientific Corp
PMA number: N970003
Supplement: S273
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (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.