PMA P010023S001
- Device
- SOUNDTEC DIRECT IPCA SYSTEM
- Applicant
- Ototronix, LLC
- PMA number
- P010023
- Supplement
- S001
- Product code
- MPV
- Decision date
- 2002-09-04
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Approval order statement
- APPROVAL FOR THE SOUNDTEC DIRECT IPCA SYSTEM. THE INDICATIONS FOR USE HAS NOT BEEN CHANGED.
Current openFDA PMA Record#
- Device
- SOUNDTEC DIRECT IPCA SYSTEM
- Applicant
- Ototronix, LLC
- PMA number
- P010023
- Supplement
- S001
- Product code
- MPV
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Decision date
- 2002-09-04
- Decision code
- APPR
- Date received
- 2001-11-21
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE SOUNDTEC DIRECT IPCA SYSTEM. THE INDICATIONS FOR USE HAS NOT BEEN CHANGED.