PMA P970051S230
- Device
- Cochlear™ Slimline™ Coil, Cochlear™ Slimline™ Coil (5(I)), Nucleus® 7 Aqua+ Coil (5(I)), Nucleus 7 Aqua+ Coil
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S230
- Product code
- MCM
- Decision date
- 2024-10-25
- Classification
- Ear, Nose, Throat
- Generic name
- Implant, cochlear
- Approval order statement
- approval for manufacturing changes to the CP1000 sound processor coil
Current openFDA PMA Record#
- Device
- Cochlear™ Slimline™ Coil, Cochlear™ Slimline™ Coil (5(I)), Nucleus® 7 Aqua+ Coil (5(I)), Nucleus 7 Aqua+ Coil
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S230
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2024-10-25
- Decision code
- OK30
- Date received
- 2024-09-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for manufacturing changes to the CP1000 sound processor coil