|
Device | INSYNC CRT-P & INSYNC III CRT-P |
Generic Name | Drug eluting permanent left ventricular (lv) pacemaker electrode |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P010015 |
Supplement Number | S087 |
Date Received | 05/20/2010 |
Decision Date | 07/15/2010 |
Product Code |
OJX |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR AN UPDATE TO COMPONENT PLANTING SPECIFICATION TITLED ¿MATERIAL, PLANTING, AND SURFACE FINISH REQUIREMENTS FOR TERMINALS FOR LASER RIBBON-BONDING (LRB), WIREBONDING (WB), AND PARALLEL GAP WELDING (PGW).¿ (REVISION O). |
Post-Approval Study | Show Report Schedule and Study Progress |