COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA premarket approval P000025/S041 · decided 2009-09-03
Approval details
- PMA number
- P000025
- Supplement
- S041
- Supplement type
- 135 Review Track For 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
- 2009-04-22
- Decision date
- 2009-09-03
- Days to decision
- 134 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR THE ADDITION OF A SECOND SOURCE SUPPLIER FOR THE FEEDTHROUGH ASSEMBLY.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.