CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT (ADULT) FLEX LEAD ELECTRODE
FDA premarket approval P940022/S008 · decided 1999-02-19
Approval details
- PMA number
- P940022
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT (ADULT) FLEX LEAD ELECTRODE
- Applicant
- Advanced Bionics Corp.
- Date received
- 1998-09-03
- Decision date
- 1999-02-19
- Days to decision
- 169 days
- Decision code
- APPR
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for a manufacturing process change in which the implantable cochlear stimulator (ICS) case will be darkened using titanium.
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