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SOUNDTEC DIRECT SYSTEM

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
OTOTRONIX, LLC
Trade Name
SOUNDTEC DIRECT SYSTEM
Generic Name
Implant, hearing, active, middle ear, partially implanted
Decision Date
9/7/2001
Days to Decision
147 days
Decision Code
APPR
FDA Decision
Approval

SOUNDTEC DIRECT SYSTEM

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
OTOTRONIX, LLC
Trade Name
SOUNDTEC DIRECT SYSTEM
Generic Name
Implant, hearing, active, middle ear, partially implanted
Decision Date
9/7/2001
Days to Decision
147 days
Decision Code
APPR
FDA Decision
Approval