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Device | LIFE PULSE HIGH FREQUENCY VENTILATOR ENDOTRACHEAL TUBE ADAPTER |
Generic Name | VENTILATOR, HIGH FREQUENCY |
Applicant | BUNNELL, INC. 436 LAWNDALE DR. SALT LAKE CITY, UT 84115 |
PMA Number | P850064 |
Supplement Number | S012 |
Date Received | 04/11/1997 |
Decision Date | 05/16/1997 |
Product Code |
LSZ |
Advisory Committee |
Anesthesiology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A LABELING CHANGE TO INCLUDE AN ADDITIONAL WARNING ADVISING AGAINST TROUBLESHOOTING WHILE THE VENTILATOR IS IN OPERATION. |