| 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 | KRONOS LV-T CRT-D & LUMAX VR/DR/HF (-T) ICDS & CDT-DS |
|---|
| Classification Name | defibrillator, implantable, dual-chamber |
|---|
| Applicant | BIOTRONIK, INC. |
|---|
| PMA Number | P050023 |
|---|
| Supplement Number | S006 |
|---|
| Date Received | 07/13/2007 |
|---|
| Decision Date | 12/07/2007 |
|---|
| Product Code | |
| Advisory Committee |
Cardiovascular |
|---|
| Supplement Type | normal 180 day track |
|---|
| Supplement Reason | change design/components/specifications - software |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product |
No
|
|---|
Approval Order Statement
Approval for the application software version a-k00. 10u of the pms/tms 1000, and application software version 703. U/1 of the ics 3000. |
|
|
