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. |
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Device | TEROX RV /KAINOX SL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR/LEAD MODELS |
Generic Name | TESTER, PACEMAKER ELECTRODE FUNCTION |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P980023 |
Supplement Number | S005 |
Date Received | 06/25/2001 |
Decision Date | 10/24/2001 |
Product Codes |
DTA DTE KRG LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE LEGALLY MARKETED KAINOX RV AND KAINOX SL LEAD SYSTEMS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TEROX RV 65 (MODEL 332 232), TEROX RV 75 (MODEL 332 231),KAINOX SL 65/13 (MODEL 124 235),KAINOX SL 65/16 (MODEL 124 236), KAINOX SL 65/18 (MODEL 124 237), AND IS INDICATED FOR USE WITH LEGALLY MARKETED BIOTRONIK IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD). |
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