NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM (ABI)
FDA premarket approval P000015/S008 · decided 2006-10-05
Approval details
- PMA number
- P000015
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM (ABI)
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2006-09-05
- Decision date
- 2006-10-05
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- ADDITIONAL ETHYLENE OXIDE (EO) STERILIZER AND CHANGE TO A NEW SIZE OF ETHYLENE OXIDE CANISTER.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.