COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA premarket approval P000025/S048 · decided 2010-10-01
Approval details
- PMA number
- P000025
- Supplement
- S048
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2010-05-19
- Decision date
- 2010-10-01
- Days to decision
- 135 days
- Decision code
- OK30
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- ADDITION OF ANOTHER SUPPLIER FOR THE FEEDTHROUGH ASSEMBLY COMPONENT.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.