|
Device | ATTAIN ABILITY LEAD & ATTAIN PERFORMA LEAD |
Generic Name | Drug eluting permanent left ventricular (lv) pacemaker electrode |
Applicant | MEDTRONIC Inc. 710 MEDTRONIC PARKWAY NE MINNEAPOLIS, MN 55432 |
PMA Number | P080006 |
Supplement Number | S104 |
Date Received | 11/28/2016 |
Decision Date | 12/19/2016 |
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 Updates to the inspection procedure for Titanium Dioxide containing pigment paste to allow usage of a new test method. |