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: MODEL 9310 LUNG WATER COMPUTER
• Generic Name: MONITOR, LUNG WATER MEASUREMENT
• Regulation Number: 868.2450
• Applicant: Edwards Lifesciences, LLC; One Edwards Way; Irvine, CA 92614
• PMA Number: P800003
• Supplement Number: S001
• Date Received: 03/17/1981
• Decision Date: 06/12/1981
• Withdrawal Date: 09/10/2007
• Product Code: JEZ
• Advisory Committee: Anesthesiology
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No