Prestige LP Cervical Disc Two Level
FDA premarket approval P090029/S012 · decided 2019-07-12
Approval details
- PMA number
- P090029
- Supplement
- S012
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Prestige LP Cervical Disc Two Level
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Date received
- 2019-05-23
- Decision date
- 2019-07-12
- Days to decision
- 50 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
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