PMA P960058S037
- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S037
- Product code
- MCM
- Decision date
- 2004-07-23
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- APPROVAL FOR EXPANSION OF THE IN-PROCESS INSPECTION PROCEDURE FOR THE HIRES 90K IMPLANT. NAMELY, THE PMA SUPPLEMENT PROPOSED TO ADD AN ADDITIONAL VISUAL INSPECTION STEP TO ENSURE WELD INTEGRITY BY USING A MINIMUM OF 80X MAGNIFICATION TO VERIFY THE FOLLOWING: 1) COMPLETE CLOSURE OF THE WELD HOLD, 2) ACCEPTABLE WELD QUALITY, AND 3) ABSENCE OF FOREIGN MATERIAL AT THE WELD SITE.
Current openFDA PMA Record#
- Device
- HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S037
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2004-07-23
- Decision code
- APPR
- Date received
- 2004-05-10
- Supplement type
- Special (Immediate Track)
- Approval order statement
- APPROVAL FOR EXPANSION OF THE IN-PROCESS INSPECTION PROCEDURE FOR THE HIRES 90K IMPLANT. NAMELY, THE PMA SUPPLEMENT PROPOSED TO ADD AN ADDITIONAL VISUAL INSPECTION STEP TO ENSURE WELD INTEGRITY BY USING A MINIMUM OF 80X MAGNIFICATION TO VERIFY THE FOLLOWING: 1) COMPLETE CLOSURE OF THE WELD HOLD, 2) ACCEPTABLE WELD QUALITY, AND 3) ABSENCE OF FOREIGN MATERIAL AT THE WELD SITE.