NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
FDA premarket approval P130022 · decided 2015-05-08
Approval details
- PMA number
- P130022
- Trade name
- NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Nevro Corporation
- Date received
- 2013-10-02
- Decision date
- 2015-05-08
- Days to decision
- 583 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- APPROVAL FOR THE NEVRO SENZA SCS SYSTEM. THIS DEVICE IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THEFOLLOWING: FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN, AND LEG PAIN.
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