PMA P000025S046
- Device
- MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S046
- Product code
- MCM
- Decision date
- 2010-09-03
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- APPROVAL FOR A CHANGE IN MED-EL¿S SUPPLIER OF A CRITICAL COMPONENT WITH DIRECT IMPACT ON THE SAFETY AND EFFICACY OF THE SONATA IMPLANTS.
Current openFDA PMA Record#
- Device
- MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S046
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2010-09-03
- Decision code
- APPR
- Date received
- 2010-03-18
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE IN MED-EL¿S SUPPLIER OF A CRITICAL COMPONENT WITH DIRECT IMPACT ON THE SAFETY AND EFFICACY OF THE SONATA IMPLANTS.