EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR
FDA premarket approval P850035/S042 · decided 2016-03-18
Approval details
- PMA number
- P850035
- Supplement
- S042
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR
- Generic name
- Stimulator, invasive bone growth
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2016-02-19
- Decision date
- 2016-03-18
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- Approval for the addition of the following contraindication to the labeling: Any case where SpF Spinal Fusion Stimulators could come into contact with metallic implant components (i.e., those that contain a mixture of Titanium, Cobalt Chrome, and Stainless Steel).
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