PMA P960058S035
- Device
- HIRESOLUTION & CLARION CII BIONIC EAR SYSTEMS
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S035
- Product code
- MCM
- Decision date
- 2004-05-14
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- EXPANSION OF STERILIZATION CAPACITY USING AN ALTERNATE STERILIZATION CHAMBER.
Current openFDA PMA Record#
- Device
- HIRESOLUTION & CLARION CII BIONIC EAR SYSTEMS
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S035
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2004-05-14
- Decision code
- OK30
- Date received
- 2004-04-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- EXPANSION OF STERILIZATION CAPACITY USING AN ALTERNATE STERILIZATION CHAMBER.