EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR
FDA premarket approval P850035/S018 · decided 1996-01-16
Approval details
- PMA number
- P850035
- Supplement
- S018
- 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
- 1995-12-08
- Decision date
- 1996-01-16
- Days to decision
- 39 days
- Decision code
- APPR
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- APPROVAL FOR REVISIONS TO THE PATIENT BROCHURE TITLED "ANSWERS TO YOUR QUESTIONS ABOUTTHE SPF SPINAL FUSION STIMULATOR." THESE CHANGES INCLUDE DELETION OF SPECIFIC, UNSUBSTNATIATED CLAIMS REGARDING PATIENTS SAFETY AND INCLUSION OF INFORMATION REGARDING DEVICE EXPLANATATION AND MRI WARNING AND PRECAUTION STATEMENTS, AS REQUESTED IN OUR JULY 18, 1995, LETTER
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