- Device
- Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S243
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2022-12-16
- Decision code
- OK30
- Date received
- 2022-11-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modify the process monitoring select ICD lead families to increase efficiency in the lead manufacturing process.