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 3100A HIGH FREQUENCY OCILLATORY VENTILATOR
• Generic Name: VENTILATOR, HIGH FREQUENCY
• Applicant: ZOLL Medical Corporation; 269 Mill Rd.; Chelsmford, MA 01824
• PMA Number: P890057
• Supplement Number: S009
• Date Received: 05/16/1997
• Decision Date: 07/08/1997
• Product Code: LSZ
• Advisory Committee: Anesthesiology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR A CHANGE IN THE MANUFACTURING OF THE PATIENT CIRCUIT TO ULTRASONIC WELDING.