| 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 | OVATIO VR 6250 & DR 6550 |
|---|
| Classification Name | defibrillator, implantable, dual-chamber |
|---|
| Generic Name | implantable cardioverter-defibrillator with active housing |
|---|
| Applicant | ELA MEDICAL, INC. |
|---|
| PMA Number | P980049 |
|---|
| Supplement Number | S041 |
|---|
| Date Received | 09/29/2008 |
|---|
| Decision Date | 02/03/2009 |
|---|
| Product Code | |
| Advisory Committee |
Cardiovascular |
|---|
| Supplement Type | real-time process |
|---|
| Supplement Reason | process change: manufacturing |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product |
No
|
|---|
Approval Order Statement
Approval for the igbt (part number 10n170) to be used in the shock 6 hybrid module t273 (scot273) for the ovatio icd and crt devices. |
|
|
