PMA P000025S074
- Device
- COMBI 40+ COCHLEAR SYSTEM
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S074
- Product code
- MCM
- Decision date
- 2014-01-17
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- CHANGES IN THE VACUUM BAKE-OUT PROCESS AND THE PREPARATION OF IN-PROCESS TEST SAMPLES.
Current openFDA PMA Record#
- Device
- COMBI 40+ COCHLEAR SYSTEM
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S074
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2014-01-17
- Decision code
- OK30
- Date received
- 2013-12-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES IN THE VACUUM BAKE-OUT PROCESS AND THE PREPARATION OF IN-PROCESS TEST SAMPLES.