PMA P050023S167

Device: Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, Defibrillator, automatic Def
Applicant: Biotronik, Inc.
PMA number: P050023
Supplement: S167
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: Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, Defibrillator, automatic Def
Applicant: Biotronik, Inc.
PMA number: P050023
Supplement: S167
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.