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: BSD 1000 HYPERTHERMIA SYSTEM
• Generic Name: System, rf/microwave hyperthermia, cancer treatment
• Applicant: Pyrexar Medical, Inc.; 1825 W. Research Way; Suite E; Salt Lake City, UT 84119
• PMA Number: P820088
• Supplement Number: S004
• Date Received: 04/23/1985
• Decision Date: 10/01/1985
• Product Code: LOC
• Advisory Committee: Radiology
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No