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 | CAPSUREFIX(R) |
Generic Name | permanent pacemaker Electrode |
Regulation Number | 870.3680 |
Applicant | Medtronic, Inc. 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P930039 |
Supplement Number | S009 |
Date Received | 03/13/2000 |
Decision Date | 08/31/2000 |
Product Code |
DTB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR AN EXTENDABLE/RETRACTABLE SCREW-IN PACING LEAD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES MEDTRONIC CAPSURE(R)FIX NOVUS MODEL 5076 AND VITATRON CRYSTALLINE(R) ACTFIX MODEL ICF09 PACING LEADS. THESE DEVICES ARE INDICATED FOR PERMANENT PACING AND SENSING OF THE VENTRICLE AND/OR ATRIUM WHEN USED WITH A COMPATIBLE PULE GENERATOR. |
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