NUCLEUS MINI 22 IMPLANT -OMIT ULTRASONIC WELD
FDA premarket approval P890027/S006 · decided 1993-05-20
Approval details
- PMA number
- P890027
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NUCLEUS MINI 22 IMPLANT -OMIT ULTRASONIC WELD
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 1991-09-20
- Decision date
- 1993-05-20
- Days to decision
- 608 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.