Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: LIFEPAK CR2 Automated External Defibrillator
• Generic Name: Automated external defibrillators (non-wearable)
• Regulation Number: 870.5310
• Applicant: Physio-Control, Inc; 11811 Willows Road NE; Redmond, WA 98052
• PMA Number: P170018
• Supplement Number: S008
• Date Received: 08/26/2020
• Decision Date: 09/17/2020
• Product Code: MKJ
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
Allow the Energy Storage Capacitor supplier's manufacturing process to confirm the shorting bar component meets its dimensional requirements.