PMA P000028S004
- Device
- AFFINITY ANTERIOR CERVICAL CAGE SYSTEM
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- PMA number
- P000028
- Supplement
- S004
- Product code
- MAX
- Decision date
- 2003-11-13
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Approval order statement
- APPROVAL FOR A REVISED EXPLANT PROTOCOL.
Current openFDA PMA Record#
- Device
- AFFINITY ANTERIOR CERVICAL CAGE SYSTEM
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- PMA number
- P000028
- Supplement
- S004
- Product code
- MAX
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Decision date
- 2003-11-13
- Decision code
- APPR
- Date received
- 2003-08-27
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- APPROVAL FOR A REVISED EXPLANT PROTOCOL.