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Spiration® Valve System

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
Gyrus ACMI, Inc.
Trade Name
Spiration® Valve System
Generic Name
Valve, pulmonary
Decision Date
12/3/2018
Days to Decision
301 days
Decision Code
APPR
FDA Decision
Approval

Spiration® Valve System

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
Gyrus ACMI, Inc.
Trade Name
Spiration® Valve System
Generic Name
Valve, pulmonary
Decision Date
12/3/2018
Days to Decision
301 days
Decision Code
APPR
FDA Decision
Approval