|
Device | MEDTRONIC 4195 ATTAIN STARFIX MODEL 4195 LV LEAD |
Generic Name | Permanent defibrillator electrodes |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P060039 |
Supplement Number | S062 |
Date Received | 08/22/2014 |
Decision Date | 09/12/2014 |
Product Code |
NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF THE REQUEST TO CLOSE THE CHRONIC EXTRACTION POST-APPROVAL STUDY FOR THE DEVICE. |