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
| Device | EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR |
| Classification Name | Stimulator, Invasive Bone Growth |
| Generic Name | Stimulator, Invasive Bone Growth |
| Applicant | EBI, LLC |
| Date Received | 1995-12-08 |
| Decision Date | 1996-01-16 |
| PMA | P850035 |
| Supplement | S018 |
| Product Code | LOE |
| Advisory Committee | Orthopedic |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | EBI, LLC 399 Jefferson Road parsippany, NJ 07054 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P850035 | | Original Filing |
| S058 |
2022-10-28 |
30-day Notice |
| S057 |
2022-05-27 |
Real-time Process |
| S056 |
2021-01-21 |
30-day Notice |
| S055 |
2019-06-21 |
30-day Notice |
| S054 | | |
| S053 |
2018-04-09 |
30-day Notice |
| S052 |
2018-04-04 |
30-day Notice |
| S051 |
2018-04-02 |
135 Review Track For 30-day Notice |
| S050 |
2018-03-29 |
30-day Notice |
| S049 |
2018-03-09 |
30-day Notice |
| S048 |
2018-03-01 |
30-day Notice |
| S047 |
2018-02-21 |
30-day Notice |
| S046 |
2018-02-13 |
30-day Notice |
| S045 |
2017-05-04 |
30-day Notice |
| S044 |
2017-03-14 |
30-day Notice |
| S043 |
2016-10-31 |
Special (immediate Track) |
| S042 |
2016-02-19 |
Special (immediate Track) |
| S041 |
2015-12-17 |
30-day Notice |
| S040 |
2015-11-19 |
30-day Notice |
| S039 |
2015-10-08 |
30-day Notice |
| S038 |
2014-08-20 |
30-day Notice |
| S037 | | |
| S036 |
2013-09-06 |
30-day Notice |
| S035 |
2013-04-30 |
30-day Notice |
| S034 |
2012-02-01 |
30-day Notice |
| S033 |
2008-07-22 |
Normal 180 Day Track No User Fee |
| S032 |
2008-07-17 |
30-day Notice |
| S031 |
2007-02-23 |
Real-time Process |
| S030 |
2004-06-09 |
Normal 180 Day Track |
| S029 |
2002-06-13 |
Normal 180 Day Track |
| S028 |
2000-05-30 |
Real-time Process |
| S027 | | |
| S026 | | |
| S025 |
2000-03-31 |
Normal 180 Day Track |
| S024 |
1998-07-06 |
Normal 180 Day Track |
| S023 |
1998-04-09 |
Real-time Process |
| S022 |
1997-04-08 |
Real-time Process |
| S021 |
1996-10-17 |
Normal 180 Day Track |
| S020 |
1996-07-19 |
Normal 180 Day Track |
| S019 |
1996-03-13 |
Normal 180 Day Track |
| S018 |
1995-12-08 |
Special (immediate Track) |
| S017 |
1994-11-22 |
Normal 180 Day Track |
| S016 |
1994-11-15 |
Normal 180 Day Track |
| S015 | | |
| S014 | | |
| S013 |
1992-03-27 |
Normal 180 Day Track |
| S012 |
1991-05-10 |
Normal 180 Day Track |
| S011 | | |
| S010 |
1990-10-25 |
Normal 180 Day Track |
| S009 | | |
| S008 |
1990-05-31 |
Normal 180 Day Track |
| S007 |
1988-12-16 |
Normal 180 Day Track |
| S006 |
1988-10-12 |
Normal 180 Day Track |
| S005 |
1988-04-18 |
Normal 180 Day Track |
| S004 |
1988-03-16 |
Normal 180 Day Track |
| S003 |
1988-02-26 |
Normal 180 Day Track |
| S002 |
1988-01-15 |
Normal 180 Day Track |
| S001 | | |
NIH GUDID Devices