AFFINITY ANTERIOR CERVICAL CAGE SYSTEM
FDA premarket approval P000028/S008 · decided 2006-07-25
Approval details
- PMA number
- P000028
- Supplement
- S008
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- AFFINITY ANTERIOR CERVICAL CAGE SYSTEM
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Date received
- 2006-04-20
- Decision date
- 2006-07-25
- Days to decision
- 96 days
- Decision code
- APPR
- Product code
- MAX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR CHANGES TO THE DEVICE LABELING TO INCORPORATE DATA COLLECTED FROM THE POST MARKET STUDY OF THE DEVICE.
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