PMA P950037S207
- Device
- Pulse Generator, Permanent, Implantable
- Applicant
- Biotronik, Inc.
- Product code
- DXY
- Decision date
- 2020-05-11
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Approval for optimization changes of the MnO2 thermal treatment process and automation of ICD battery cathode manufacturing.
Current openFDA PMA Record#
- Device
- Pulse Generator, Permanent, Implantable
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S207
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2020-05-11
- Decision code
- APPR
- Date received
- 2019-11-22
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for optimization changes of the MnO2 thermal treatment process and automation of ICD battery cathode manufacturing.