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Trade Name | SPIRATION VALVE SYSTEM (INCLUDING AIRWAY SIZING KIT) |
Classification Name | one-way air-leak valve |
Generic Name | one-way air-leak valve |
Applicant |
Gyrus ACMI, Inc. |
6675 185th avenue ne |
redmond, WA 98052 |
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HDE Number | H060002 |
Supplement Number | S009 |
Date Received | 11/27/2015 |
Decision Date | 12/22/2015 |
Product Code | |
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 the addition of a contraindication and changes in the instructions for use. |