PMA P980023S105

Device: PSW 2100.U and NEO 2100.U
Applicant: Biotronik, Inc.
PMA number: P980023
Supplement: S105
Product code: LWS
Decision date: 2021-04-30
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: Approval for updates to programmer software to versions PSW 2100.U and NEO 2100.U to reduce the number of capacitor reformations and move the timepoint for capacitor reformations from overnight to daytime for various Biotronik implantable cardiac devices.

Current openFDA PMA Record#

Device: PSW 2100.U and NEO 2100.U
Applicant: Biotronik, Inc.
PMA number: P980023
Supplement: S105
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2021-04-30
Decision code: APPR
Date received: 2021-03-16
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for updates to programmer software to versions PSW 2100.U and NEO 2100.U to reduce the number of capacitor reformations and move the timepoint for capacitor reformations from overnight to daytime for various Biotronik implantable cardiac devices.