PMA P010023S013
- Device
- SOUNDTECH DIRECT AND MAXUM
- Applicant
- Ototronix, LLC
- PMA number
- P010023
- Supplement
- S013
- Product code
- MPV
- Decision date
- 2016-03-22
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Approval order statement
- Approval for a test fixture and inspection process change for the Magnet Canister Assembly (MCA).
Current openFDA PMA Record#
- Device
- SOUNDTECH DIRECT AND MAXUM
- Applicant
- Ototronix, LLC
- PMA number
- P010023
- Supplement
- S013
- Product code
- MPV
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Decision date
- 2016-03-22
- Decision code
- APPR
- Date received
- 2015-09-15
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a test fixture and inspection process change for the Magnet Canister Assembly (MCA).