MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM; MED-EL COMBI 40+ (STANDARD), COMBI 40+S (COMPRESSED), AND COMBI 40+ GB (SPLITS
FDA premarket approval P000025/S008 · decided 2003-03-25
Approval details
- PMA number
- P000025
- Supplement
- S008
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM; MED-EL COMBI 40+ (STANDARD), COMBI 40+S (COMPRESSED), AND COMBI 40+ GB (SPLITS
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2003-01-21
- Decision date
- 2003-03-25
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR THE FOLLOWING CHANGES IN THE LABELING: 1) INFORMATIONAL STATEMENTS REGARDING MENINGITIS, THE USE OF PROPHYLACTIC ANTIBIOTICS, AND VACCINATIONS 2) INFORMATIONAL STATEMENTS REGARDING ELECTROSTATIC DISCHARGE (ESD) PREVENTIONS.
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