PMA P070008S165
- Device
- Sentus QP Pacing Leads
- Applicant
- Biotronik, Inc.
- PMA number
- P070008
- Supplement
- S165
- Product code
- NKE
- Decision date
- 2025-06-12
- Classification
- Cardiovascular
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- approval for a labeling update to include the findings of the Sentus QP EP PASSION Post-Approval Study
Current openFDA PMA Record#
- Device
- Sentus QP Pacing Leads
- Applicant
- Biotronik, Inc.
- PMA number
- P070008
- Supplement
- S165
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2025-06-12
- Decision code
- APPR
- Date received
- 2025-01-16
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- approval for a labeling update to include the findings of the Sentus QP EP PASSION Post-Approval Study