PMA P070008S104
- Device
- sentus QP LV Lead
- Applicant
- Biotronik, Inc.
- Product code
- NKE
- Decision date
- 2019-09-24
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- Approval of the revised protocols (Versions May 6, 2019 and September 6, 2019) for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- sentus QP LV Lead
- Applicant
- Biotronik, Inc.
- PMA number
- P070008
- Supplement
- S104
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2019-09-24
- Decision code
- APPR
- Date received
- 2019-05-14
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocols (Versions May 6, 2019 and September 6, 2019) for the post-approval study (PAS) protocol.