Prospera SCS System Next Generation Active Anchor, TrueLock
FDA premarket approval P210037/S002 · decided 2024-02-15
Approval details
- PMA number
- P210037
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Prospera SCS System Next Generation Active Anchor, TrueLock
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Biotronik Nro, Inc.
- Date received
- 2023-07-25
- Decision date
- 2024-02-15
- Days to decision
- 205 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- Approval for the Prospera Spinal Cord Stimulation (SCS) System Next Generation Active Anchor, TrueLock. The Indications for Use (IFU) of the device is as follows:The Prospera spinal cord stimulation (SCS) system is indicated as an aid in the management of chronic, intractable pain in the trunk and/or limbs, which may include unilateral or bilateral pain, resulting from any of the following: 1) Failed Back Syndrome (FBS) or low back syndrome or failed back; 2) Radicular pain syndrome or radiculop
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