|
Device | 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 | S065 |
Date Received | 12/03/2014 |
Decision Date | 03/11/2015 |
Product Code |
NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL AN UPDATE TO THE MANUFACTURING PROCESS OF THE BLUE TUBING USED IN THE CONSTRUCTION OF THE LEAD TO REPLACE TYGON WITH VITON. |