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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 | S030 |
Date Received | 03/31/2015 |
Decision Date | 12/23/2016 |
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 |
Approval Order Statement Approval to add the 3.0 mm ID size LifePort Adapter to the existing product line of LifePort Adapters and adhesive changes to the approved LifePort Adapters. |