BTE(BEHIND-THE-EAR)SYSTEM SENSOR (PEDIATRIC)
FDA premarket approval P960058/S022 · decided 2002-06-06
Approval details
- PMA number
- P960058
- Supplement
- S022
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BTE(BEHIND-THE-EAR)SYSTEM SENSOR (PEDIATRIC)
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2002-05-28
- Decision date
- 2002-06-06
- Days to decision
- 9 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR THE BTE SYSTEM SENSOR, AN ACCESSORY ITEM TO BE OFFERED FOR USE WITH THE BTE SOUND PROCESSOR FOR LIMITED VERIFICATION OF SYSTEM FUNCTIONALITY.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.