| Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device. |
| |
| Trade Name | CONCENTRO II CRT-D |
|---|
| Classification Name | defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) |
|---|
| Generic Name | cardiac resynchronization therapy |
|---|
| Applicant | MEDTRONIC INC. |
|---|
| PMA Number | P010031 |
|---|
| Supplement Number | S125 |
|---|
| Date Received | 09/24/2008 |
|---|
| Decision Date | 10/23/2008 |
|---|
| Product Code | |
| Advisory Committee |
Cardiovascular |
|---|
| Supplement Type | real-time process |
|---|
| Supplement Reason | change design/components/specifications - component |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product |
No
|
|---|
Approval Order Statement
Approval to implement a design change to add three new "intermediate-feature" models (concerto ii model crt-d d274trk. Virtuoso ii icd model dr d274drg and model vr d274vrc) to the approved gen 2 consulta/secura/ maxima ii family of devices (consulta crt-d d224trk, maximo ii crt-d d284trk. Secure vr d224vrc, maximo ii dr d284drg, and maximo ii d284 vrc submitted under p01003i/s084 and p980016/s114, approved march 17, 2008). |
|
|
