|
Device | Life Pulse High Frequency Ventilator |
Generic Name | VENTILATOR, HIGH FREQUENCY |
Applicant | BUNNELL, INC. 436 LAWNDALE DR. SALT LAKE CITY, UT 84115 |
PMA Number | P850064 |
Supplement Number | S045 |
Date Received | 02/16/2021 |
Decision Date | 10/13/2021 |
Product Code |
LSZ |
Advisory Committee |
Anesthesiology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a change to the manufacturing process of cutting the heater wire, including the process of stripping the ends of the cut heater wire. It is proposed that an approved vendor perform the requested tasks. |