|
Device | MODEL 4195 ATTAIN STARFIX 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 | S021 |
Date Received | 01/26/2011 |
Decision Date | 11/22/2011 |
Product Codes |
NVY OJX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Review Memo | Review Memo |
Approval Order Statement APPROVAL FOR A CHANGE IN THE REQUIREMENT FOR THE COPPER CONTENT IN THE BLUE POLYURETHANE TUBING UTILIZED BY THE MEDTRONIC ATTAIN STARFIX LEAD FROM 200 PPM TO 300 PPM. |
Approval Order | Approval Order |
Post-Approval Study | Show Report Schedule and Study Progress |