EBI SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR
FDA premarket approval P850035/S023 · decided 1998-05-01
Approval details
- PMA number
- P850035
- Supplement
- S023
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EBI SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR
- Generic name
- Stimulator, invasive bone growth
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 1998-04-09
- Decision date
- 1998-05-01
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- Approval for the addition of a 4cm mesh cathode to be used with the SpF-2T stimulator and a 8cm mesh cathode to be used with the SpF-XL IIb stimulator. The device, as modified, will be marketed under the trade names SpF-2T/CM and SpF-XL IIb 2/DM and is indicated for the same used as the SpF-2T and SpF-XL IIb.
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