PMA P950037S239
- Device
- Drug Eluting Permanent Right Ventricular (RV), Right Atrial (RA) Pacemaker Electrodes
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S239
- Product code
- DXY
- Decision date
- 2022-10-20
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Update process monitoring sampling and remove redundant testing and inspection processes.
Current openFDA PMA Record#
- Device
- Drug Eluting Permanent Right Ventricular (RV), Right Atrial (RA) Pacemaker Electrodes
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S239
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2022-10-20
- Decision code
- OK30
- Date received
- 2022-09-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update process monitoring sampling and remove redundant testing and inspection processes.