SONATATI100 IMPLANT
FDA premarket approval P000025/S043 · decided 2009-09-23
Approval details
- PMA number
- P000025
- Supplement
- S043
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SONATATI100 IMPLANT
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2009-07-31
- Decision date
- 2009-09-23
- Days to decision
- 54 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR THE CREATION OF A FITTING GUIDE FOR MAESTRO 3.0 AND THE SPEECH PROCESSORS OPUS1 AND OPUS2.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.