HIRESOLUTION BIONIC EAR SYSTEM
FDA premarket approval P960058/S066 · decided 2008-10-15
Approval details
- PMA number
- P960058
- Supplement
- S066
- Supplement type
- 135 Review Track For 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
- 2008-06-02
- Decision date
- 2008-10-15
- Days to decision
- 135 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR AN IMPROVED AUTOMATED TEST SYSTEM FOR THE HIRES90K.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.