NUVASIVE PCM CERVICAL DISC SYSTEM
FDA premarket approval P100012/S005 · decided 2014-03-07
Approval details
- PMA number
- P100012
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUVASIVE PCM CERVICAL DISC SYSTEM
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Nuvasive, Inc.
- Date received
- 2013-12-18
- Decision date
- 2014-03-07
- Days to decision
- 79 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR DESIGN CHANGES TO THE PCM INSERTER AND REDEFINING AND TIGHTENING IMPLANT TOLERANCES.
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