|
Device | EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR |
Generic Name | Stimulator, invasive bone growth |
Applicant | EBI, LLC 1 Gatehall Drive Suite 303 Parsippany, NJ 07054 |
PMA Number | P850035 |
Supplement Number | S018 |
Date Received | 12/08/1995 |
Decision Date | 01/16/1996 |
Product Code |
LOE |
Advisory Committee |
Orthopedic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order 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 |