PMA P000025S083
- Device
- COMBI 40+ COCHLEAR IMPLANT SYSTEM (MAESTRO COCHLEAR IMPLANT SYSTEM)
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S083
- Product code
- MCM
- Decision date
- 2015-12-29
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- ALTERNATIVES TO BATCH TESTING FOR BACTERIAL ENDOTOXINS AND ESTABLISHMENT OF A DYNAMIC SAMPLING PLAN.
Current openFDA PMA Record#
- Device
- COMBI 40+ COCHLEAR IMPLANT SYSTEM (MAESTRO COCHLEAR IMPLANT SYSTEM)
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S083
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2015-12-29
- Decision code
- OK30
- Date received
- 2015-11-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALTERNATIVES TO BATCH TESTING FOR BACTERIAL ENDOTOXINS AND ESTABLISHMENT OF A DYNAMIC SAMPLING PLAN.