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- ESIPolymer, Natural-Absorbable Gelatin Material3Product Code
- EWDProtector, Hearing (Insert)UProduct Code
- EWEProtector, Hearing (Circumaural)UProduct Code
- LEZAids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)UProduct Code
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- LFBButton, Nasal SeptalUProduct Code
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- LXVApparatus, Vestibular AnalysisUProduct Code
- MCMImplant, Cochlear3Product Code
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- MPVImplant, Hearing, Active, Middle Ear, Partially Implanted3Product Code
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- QNUTranscutaneous Electrical Nerve Stimulator For The Relief Of Congestion2Product Code
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- OWODrug-Eluting Sinus Stent3Product Code
- PGQCochlear Implant With Combined Electrical Stimulation And Acoustic Amplification3Product Code
- QJATympanostomy Tube Delivery Product With Drug3Product Code
- QOOVentilator Tubing And AccessoriesNProduct Code
- QOPRespiratory Humidifier For Emergency UseNProduct Code
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- QQGOropharyngeal Electrical Stimulator2Product Code
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- QXGCooperative Powered Surgical Assist Device For Ent Surgery2Product Code
- QZCExternal Mechanical Stimulator For The Relief Of Congestion2Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
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- Subpart G—Miscellaneous DevicesCFR Sub-Part
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Tula® System
- Page Type
- PMA Approval
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- Tusker Medical, Inc.
- Trade Name
- Tula® System
- Generic Name
- Tympanostomy tube delivery product with drug
- Decision Date
- 11/25/2019
- Days to Decision
- 178 days
- Decision Code
- APPR
- FDA Decision
- Approval