PMA P050023S141
- Device
- Stylet Catheter, Implantable Cardioverter Defibrillator, Implantable Dual-Chamber Defibrillator, Defibrillator Automatic
- Applicant
- Biotronik, Inc.
- PMA number
- P050023
- Supplement
- S141
- Product code
- MRM
- Decision date
- 2020-01-29
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Approval order statement
- Introduce three new sterilization chambers.
Current openFDA PMA Record#
- Device
- Stylet Catheter, Implantable Cardioverter Defibrillator, Implantable Dual-Chamber Defibrillator, Defibrillator Automatic
- Applicant
- Biotronik, Inc.
- PMA number
- P050023
- Supplement
- S141
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- 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.