PMA P950037S222
- Device
- Pulse Generator, Permanent, Implantable
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S222
- Product code
- DXY
- Decision date
- 2021-06-02
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Introduce changes to the battery feedthroughs.
Current openFDA PMA Record#
- Device
- Pulse Generator, Permanent, Implantable
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S222
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- 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.