Qualification of an alternate supplier to provide electronic printed circuit boards (pcbs) for the three device systems. The change is being made to qualify an alternate secondary-supplier for the pcbs to complement existing approved suppliers in order to further secure the supply chain for critical components to these device systems. The following zimmer biomet manufacturing and distribution facility is affected by the changes: ebi patient care inc. , guaynabo, puerto rico.
| Device | BIOMET EBI BONE HEALING SYSTEM |
| Classification Name | Stimulator, Bone Growth, Non-invasive |
| Generic Name | Stimulator, Bone Growth, Non-invasive |
| Applicant | EBI, LLC |
| Date Received | 2016-11-08 |
| Decision Date | 2016-12-08 |
| PMA | P790002 |
| Supplement | S036 |
| Product Code | LOF |
| Advisory Committee | Orthopedic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | EBI, LLC 399 Jefferson Road parsippany, NJ 07054 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P790002 | | Original Filing |
| S038 |
2022-10-28 |
30-day Notice |
| S037 |
2018-03-01 |
30-day Notice |
| S036 |
2016-11-08 |
30-day Notice |
| S035 |
2016-02-11 |
30-day Notice |
| S034 |
2015-12-17 |
30-day Notice |
| S033 |
2015-10-08 |
30-day Notice |
| S032 |
2014-04-10 |
30-day Notice |
| S031 |
2014-02-07 |
Real-time Process |
| S030 |
2013-08-13 |
Special (immediate Track) |
| S029 |
2012-12-04 |
30-day Notice |
| S028 |
2012-05-16 |
Normal 180 Day Track |
| S027 |
2011-08-11 |
30-day Notice |
| S026 |
2010-06-29 |
Normal 180 Day Track |
| S025 |
2007-04-06 |
Real-time Process |
| S024 | | |
| S023 |
2005-06-17 |
Real-time Process |
| S022 |
2002-04-08 |
Normal 180 Day Track |
| S021 |
1999-11-30 |
Real-time Process |
| S020 |
1998-12-22 |
Real-time Process |
| S019 |
1998-06-24 |
Real-time Process |
| S018 |
1997-02-10 |
Normal 180 Day Track |
| S017 | | |
| S016 |
1995-06-02 |
Normal 180 Day Track |
| S015 |
1994-07-19 |
Normal 180 Day Track |
| S014 |
1992-09-28 |
Normal 180 Day Track |
| S013 |
1991-10-28 |
Normal 180 Day Track |
| S012 |
1989-08-07 |
Normal 180 Day Track |
| S011 |
1989-04-14 |
Normal 180 Day Track |
| S010 |
1989-03-02 |
Normal 180 Day Track |
| S009 |
1987-06-11 |
Normal 180 Day Track |
| S008 |
1986-10-16 |
Normal 180 Day Track |
| S007 | | |
| S006 |
1985-04-15 |
|
| S005 | | |
| S004 |
1983-03-02 |
|
| S003 |
1982-09-15 |
|
| S002 |
1982-07-15 |
|
| S001 |
1982-04-01 |
|
NIH GUDID Devices