COMBI 40+ COCHLEAR IMPLANT SYSTEM (MAESTRO COCHLEAR SYSTEM)
FDA premarket approval P000025/S065 · decided 2012-10-15
Approval details
- PMA number
- P000025
- Supplement
- S065
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COMBI 40+ COCHLEAR IMPLANT SYSTEM (MAESTRO COCHLEAR SYSTEM)
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2012-09-17
- Decision date
- 2012-10-15
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- ADDITION OF A NEW LASER WELDING SYSTEM FOR THE PURPOSES OF WELDING IMPLANT HOUSINGS TO IMPLANT HEADERS FOR THE MI1000 MED-EL CONCERT MODEL COCHLEAR IMPLANTS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.