PRESTIGE LP(TM) CERVICAL DISC
FDA premarket approval P090029/S003 · decided 2016-07-07
Approval details
- PMA number
- P090029
- Supplement
- S003
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PRESTIGE LP(TM) CERVICAL DISC
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Date received
- 2015-06-03
- Decision date
- 2016-07-07
- Days to decision
- 400 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- Approval for the Prestige LP Cervical Disc. This device is indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following discectomy at one level or two contiguous levels for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to abnormality localized to the level of the disc space and at least one of the following conditions confirmed by imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (de
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