|
Device | Attain StarFix 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 | P060039 |
Supplement Number | S090 |
Date Received | 09/26/2018 |
Decision Date | 10/18/2018 |
Product Code |
OJX |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Transfer receiving and incoming inspection activities for device components from Medtronic Rice Creek to Medtronic Puerto Rico Operations Company (MPROC) Villalba/Juncos sites and the FedEx/3PL (Third Party Logistics) facility in Guaynabo, Puerto Rico. |