CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) S-SERIES TM SPEECH PROCESSOR
FDA premarket approval P960058/S001 · decided 1997-09-05
Approval details
- PMA number
- P960058
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) S-SERIES TM SPEECH PROCESSOR
- Applicant
- Advanced Bionics
- Date received
- 1997-07-10
- Decision date
- 1997-09-05
- Days to decision
- 57 days
- Decision code
- APPR
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Approval for the S-Series(TM) Speech 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.