| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
| |
| Device | SELOX ST/JT STEROID-ELUTING PASSIVE-FIXATION ENDOCARDIAL PACKING LEAD MODELS SELOX ST 53, SELOX ST 60, SELOX JT 45 & 53 |
|---|
| Generic Name | implantable pacemaker Pulse-generator |
|---|
| Applicant | BIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035 |
|---|
| PMA Number | P950037 |
|---|
| Supplement Number | S038 |
|---|
| Date Received | 05/27/2004 |
|---|
| Decision Date | 11/10/2004 |
|---|
| Product Codes |
DTB DXY KRG |
| Advisory Committee |
Cardiovascular |
|---|
| Supplement Type | Normal 180 Day Track |
|---|
| Supplement Reason | Change Design/Components/Specifications/Material |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | Yes |
|---|
Approval Order Statement
APPROVAL FOR THE ADDITION OF A DRUG COLLAR TO THE PACING LEAD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SELOX ST/JT AND IS INDICATED AS FOLLOWS: SELOX ST AND SELOX JT STEROID ELUTING LEADS ARE DESIGNED FOR USE WITH IMPLANTABLE PULSE GENERATORS THAT REQUIRE PACING LEADS WITH A BIPOLAR 3.2 MM IS-1 CONNECTOR CONFIGURATION; THEY MAY BE USED WITH SINGLE OR DUAL CHAMBER PACING SYSTEMS. THE LEADS ARE DESIGNED FOR USE IN PATIENTS FOR WHOM SINGLE OR DUAL CHAMBER PULSE GENERATOR THERAPY IS MEDICALLY INDICATED. THIS INDICATION FOLLOWS THAT RECOMMENDED IN THE CLASS I DEFINITION OF THE ACC/AHA/NASPE TASK FORCE REPORT, ENTITLED "ACC/AHA/NASPE 2002 GUIDELINE UPDATE FOR IMPLANTATION OF CARDIAC PACEMAKERS AND ANTIARRHYTHMIA DEVICES: A REPORT OF THE AMERICAN COLLEGE OF CARDIOLOGY/AMERICAN HEART ASSOCIATION TASK FORCE ON PRACTICE GUIDELINES (ACC/AHA/NASPE COMMITTEE ON PACEMAKER IMPLANTATION)" (GREGORATOS ET AL. 2002). |
|
|
