PMA P070008S129
- Device
- Sentus QP leads
- Applicant
- Biotronik, Inc.
- PMA number
- P070008
- Supplement
- S129
- Product code
- NKE
- Decision date
- 2021-09-03
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- Add an alternate supplier for certain sub-assemblies of the Sentus QP leads.
Current openFDA PMA Record#
- Device
- Sentus QP leads
- Applicant
- Biotronik, Inc.
- PMA number
- P070008
- Supplement
- S129
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2021-09-03
- Decision code
- OK30
- Date received
- 2021-08-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an alternate supplier for certain sub-assemblies of the Sentus QP leads.