| Device |
artificial heart |
| Definition |
P030011 |
| Product Code | LOZ |
| Device Class |
3
|
| Premarket Approvals (PMA) |
| 2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
|
1
|
1
|
1
|
2
|
2
|
5
|
0
|
|
| Recalls |
| |
2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
| Class I |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
| Class II |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
| Class III |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
| Recalls |
| Manufacturer |
Recall Class |
Date Posted |
| 1 |
Abiomed, Inc. |
II |
Sep-20-2008 |
|
|
|