PMA P980023S114

Device: Implantable Cardioverter Defibrillator (Non-CRT)
Applicant: Biotronik, Inc.
PMA number: P980023
Supplement: S114
Product code: LWS
Decision date: 2022-06-21
Generic name: Implantable cardioverter defibrillator (non-CRT)
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)
Applicant: Biotronik, Inc.
PMA number: P980023
Supplement: S114
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
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.