HARMONY HIRESOLUTION BIONIC EAR SYSTEM
FDA premarket approval P960058/S073 · decided 2008-12-09
Approval details
- PMA number
- P960058
- Supplement
- S073
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HARMONY HIRESOLUTION BIONIC EAR SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2008-11-10
- Decision date
- 2008-12-09
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR A NEW REPAIR SERVICE FOR SPEECH PROCESSORS WITH ASSOCIATED LETTERS TO PATIENTS (ADULT, PEDIATRIC) WHICH ACCOMPANIES THE REPLACEMENT PROCESSOR.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.