|
Device | MODEL 4194 ATTAIN BIPOLAR OVER-THE-WIRE LEAD |
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 | S068 |
Date Received | 04/06/2009 |
Decision Date | 06/05/2009 |
Product Code |
OJX |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR A CHANGE TO THE DC RESISTANCE SPECIFICATION FOR THE MODEL 4194 ATTAIN BIPOLAR OVER-THE-WIRE (OTW) LEAD FAMILY. |