PMA P000025S037
- Device
- MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S037
- Product code
- MCM
- Decision date
- 2008-10-09
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- APPROVAL FOR ADDING INSPECTIONS FOR SHORT CIRCUITS IN THE MANUFACTURING OF THE SONATA AND PULSAR IMPLANTS.
Current openFDA PMA Record#
- Device
- MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S037
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2008-10-09
- Decision code
- APPR
- Date received
- 2008-09-12
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR ADDING INSPECTIONS FOR SHORT CIRCUITS IN THE MANUFACTURING OF THE SONATA AND PULSAR IMPLANTS.