PLATINUM SOUND PROCESSOR (COCHLEAR IMPLANT)
FDA premarket approval P940022/S013 · decided 2000-02-02
Approval details
- PMA number
- P940022
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PLATINUM SOUND PROCESSOR (COCHLEAR IMPLANT)
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics Corp.
- Date received
- 1999-11-12
- Decision date
- 2000-02-02
- Days to decision
- 82 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Size reduction in the speech processor known as the Platinum Sound 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.