PMA P000009S098
- Device
- Defibrillator, Implantable, dual-chamber
- Applicant
- Biotronik, Inc.
- PMA number
- P000009
- Supplement
- S098
- Product code
- MRM
- Decision date
- 2022-06-21
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Approval order statement
- Change to the temperature at which final vibration testing is conducted and transfer of final testing from a cleanroom to a grey room.
Current openFDA PMA Record#
- Device
- Defibrillator, Implantable, dual-chamber
- Applicant
- Biotronik, Inc.
- PMA number
- P000009
- Supplement
- S098
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2022-06-21
- Decision code
- OK30
- Date received
- 2022-06-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the temperature at which final vibration testing is conducted and transfer of final testing from a cleanroom to a grey room.