NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (ADULT)
FDA premarket approval P840024/S078 · decided 1999-05-07
Approval details
- PMA number
- P840024
- Supplement
- S078
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (ADULT)
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 1999-04-15
- Decision date
- 1999-05-07
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- The 30-day Notice requested a manufacturing process change from Freon to Lenium TS for use in the expansion of silicone tubing and moldings.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.