HIRESOLUTION BIONIC EAR SYSTEM
FDA premarket approval P960058/S118 · decided 2015-09-18
Approval details
- PMA number
- P960058
- Supplement
- S118
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HIRESOLUTION BIONIC EAR SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2015-08-21
- Decision date
- 2015-09-18
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- CHANGE IN LOCATION OF THE SUPPLIER OF RAW POLYETHYLENE MATERIALUSED TO MANUFACTURE BRAIDED FIBER THAT IS THEN USED IN THE HIRES 90KTM ADVANTAGE ANTENNA COIL, AND EXPANDED MATERIAL SPECIFICATIONS FOR BOTH THE RAW FIBER AND THE BRAIDED FIBER.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.