EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR MODEL SPF-XL II
FDA premarket approval P850035/S020 · decided 1996-08-20
Approval details
- PMA number
- P850035
- Supplement
- S020
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR MODEL SPF-XL II
- Generic name
- Stimulator, invasive bone growth
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 1996-07-19
- Decision date
- 1996-08-20
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- APPROVAL FOR THE SPF-XL II IMPLANTABLE SPINAL FUSION STIMULATOR SHICH IS A MODIFICATION OF THE SPF-XL IMPLANTABLE SPINAL FUSION STIMULATOR. THE SPF-XL IMPLANTABLE SPINAL FUSION STIMULATOR CONSISTS OF 4 LEADS, EACH BEING 12 CM IN LENGTH WHILE THE SPF-XL II WILL HAVE ONLY 2 LEADS, EACH BEING 24 CM IN LENGTH. THE DEVICE AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SPF-XL II IMPLANTABLE SPINAL FUSION STIMULATOR
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