Approval to add the following contraindication to the labeling: any surgical implantation procedure such as minimally invasive surgical-mis procedures requiring the spf® spinal fusion stimulators cathodes to be disconnected from their corresponding leads prior to or during implantation since this may seriously compromise the electrical performance of the implantable stimulators cathodes to deliver a constant current to the fusion site as intended.
| Device | Implantable Spinal Fusion Stimulator's: SpF® -XL IIb 2/DM, SpF® -XL IIb 2/DW, SpF® PLUS-Mini (60?A/M), SpF® PLUS-Mini (6 |
| Classification Name | Stimulator, Invasive Bone Growth |
| Generic Name | Stimulator, Invasive Bone Growth |
| Applicant | EBI, LLC |
| Date Received | 2016-10-31 |
| Decision Date | 2016-11-17 |
| PMA | P850035 |
| Supplement | S043 |
| 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