PMA P950037S209
- Device
- Drug Eluting Permanent Right Venticular/Right Atrial Pacemaker Electrodes, Stylets, Stylet, Catheter, Blind Plug, Perman
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S209
- Product code
- DXY
- Decision date
- 2020-01-29
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Introduce three new sterilization chambers.
Current openFDA PMA Record#
- Device
- Drug Eluting Permanent Right Venticular/Right Atrial Pacemaker Electrodes, Stylets, Stylet, Catheter, Blind Plug, Perman
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S209
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2020-01-29
- Decision code
- OK30
- Date received
- 2019-12-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduce three new sterilization chambers.