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: HFV STAR
• Generic Name: VENTILATOR, HIGH FREQUENCY
• Applicant: Nellcor Puritan Bennett, Inc.; 2200 Faraday Ave.; Carlsbad, CA 92008
• PMA Number: P880013
• Supplement Number: S003
• Date Received: 09/21/1993
• Decision Date: 10/26/1993
• Withdrawal Date: 08/29/2007
• Product Code: LSZ
• Advisory Committee: Anesthesiology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No