PMA P010023S002
- Device
- MAXUM SYSTEM
- Applicant
- Ototronix, LLC
- PMA number
- P010023
- Supplement
- S002
- Product code
- MPV
- Decision date
- 2009-10-08
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Approval order statement
- APPROVAL TO CHANGE THE LABELING WITH A NEW PRODUCT NAME, MAXUM SYSTEM
Current openFDA PMA Record#
- Device
- MAXUM SYSTEM
- Applicant
- Ototronix, LLC
- PMA number
- P010023
- Supplement
- S002
- Product code
- MPV
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Decision date
- 2009-10-08
- Decision code
- APPR
- Date received
- 2009-08-19
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL TO CHANGE THE LABELING WITH A NEW PRODUCT NAME, MAXUM SYSTEM