PMA P070008S177

Device: BIOexpress
Applicant: Biotronik, Inc.
PMA number: P070008
Supplement: S177
Product code: NKE
Decision date: 2026-10-16
Classification: Cardiovascular
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement: BIOexpress, a dedicated interrogation-only device for status checks of BIOTRONIK implantable pulse generators (IPGs, CRT-Ps), implantable cardioverter defibrillators (ICDs, CRT-Ds) and implantable cardiac monitors (ICMs)

Current openFDA PMA Record#

Device: BIOexpress
Applicant: Biotronik, Inc.
PMA number: P070008
Supplement: S177
Product code: NKE
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date: 2026-10-16
Decision code: APPR
Date received: 2026-03-13
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: BIOexpress, a dedicated interrogation-only device for status checks of BIOTRONIK implantable pulse generators (IPGs, CRT-Ps), implantable cardioverter defibrillators (ICDs, CRT-Ds) and implantable cardiac monitors (ICMs)