MED-EL Cochlear Implants
FDA premarket approval P000025/S098 · decided 2018-04-20
Approval details
- PMA number
- P000025
- Supplement
- S098
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MED-EL Cochlear Implants
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2018-01-22
- Decision date
- 2018-04-20
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- Approval for the following changes to the Medical Procedures Manual (MPM) AW33290 EN US of the labeling: 1) Change to allow diagnostic ultrasound exposure for MED-EL Cochlear Implants;2) Changes related to MRI (MPM section "Magnetic Resonance Imaging (MRI) Safety Information");3) Addition of some introductory text;4) Correction of MRI condition for SONATA and Mi1000 CONCERT (PIN); and5) Editorial changes.
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