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 | FINISHING WIRE UNIVERSAL |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S013 |
Date Received | 04/25/2003 |
Decision Date | 06/09/2003 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE FINISHING WIRE CAP SECTION OF THE COMMERCIALLY AVAILABLE FINISHING WIRE UNIVERSAL WHICH WILL ALLOW IT TO BE COMPATIBLE WITH THE IS-1 TERMINAL PIN AS WELL AS THE LV-1 TERMINAL PIN OF THE EASYTRAK LEADS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FINISHING WIRE UNIVERSAL, MODELS 6001-6007 AND IS INDICATED FOR USE WITH GUIDANT CORONARY VENDUS LEADS. |
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