PMA P070008S124
- Device
- Pulse Generator, Pacemaker, Implantable, with Cardiac Resynchronization (CRT-P)
- Applicant
- Biotronik, Inc.
- PMA number
- P070008
- Supplement
- S124
- Product code
- NKE
- Decision date
- 2021-06-02
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- Introduce changes to the battery feedthroughs.
Current openFDA PMA Record#
- Device
- Pulse Generator, Pacemaker, Implantable, with Cardiac Resynchronization (CRT-P)
- Applicant
- Biotronik, Inc.
- PMA number
- P070008
- Supplement
- S124
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2021-06-02
- Decision code
- OK30
- Date received
- 2021-05-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduce changes to the battery feedthroughs.