MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM STERILE BLISTERS WITH INTERNAL ANTIBLOCK
FDA premarket approval P000025/S047 · decided 2010-09-03
Approval details
- PMA number
- P000025
- Supplement
- S047
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM STERILE BLISTERS WITH INTERNAL ANTIBLOCK
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2010-04-28
- Decision date
- 2010-09-03
- Days to decision
- 128 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR A CHANGE IN THE PRODUCTION OF THE THERMOFORMING FOIL USED TO PRODUCE THE BLISTERS OF THE STERILE PACKAGE FOR THE 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.