HIRESOLUTION BIONIC EAR SYSTEM
FDA premarket approval P960058/S057 · decided 2007-07-27
Approval details
- PMA number
- P960058
- Supplement
- S057
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HIRESOLUTION BIONIC EAR SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2007-04-18
- Decision date
- 2007-07-27
- Days to decision
- 100 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR THE REVISION OF THE MANUFACTURING SPECIFICATION SOP (MS0037) TO INCLUDE AN ADDITIONAL VACUUM/BACKFILL CYCLE.
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