EBI SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR
FDA premarket approval P850035/S022 · decided 1997-04-22
Approval details
- PMA number
- P850035
- Supplement
- S022
- 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
- 1997-04-08
- Decision date
- 1997-04-22
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- APPROVAL FOR THE SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR WHICH IS A MODIFICATION OF THE SPF-XL II IMPLANTABLE SPINAL FUSION STIMULATOR. THE SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR HAS A SMALLER GENERATOR CASE THAN THE SPF-XL II IMPLANTALBLE SPINAL FUSION STIMULATOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THE SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR AND IS INDICATED FOR USE AS A SPINAL FUSION ADJUNCT TO INCREASE THE PROBABILITY OF FUSION SUCCESS IN 3
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