|
Device | ATTAIN PERFORMA |
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 | S078 |
Date Received | 04/03/2015 |
Decision Date | 04/28/2015 |
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 THE FOLLOWING MANUFACTURING CHANGES:1) THE ADDITION OF AN ALTERNATIVE TESTING SYSTEM FOR ELECTRODE COMPONENTS; 2) USE OF FACTORYWORKS RELEASE 7.9 MANUFACTURING SOFTWARE; 3) A REDUCTION IN THE EXPOSURE TIME DURING ETHYLENE OXIDE HALF-CYCLE TESTING; 4) A REDUCTION IN THE FREQUENCY OF ENVIRONMENTAL MONITORING TESTING IN SPECIFICMANUFACTURING AREAS; 5) AN UPDATE TO THE MAXIMUM STERILIZATION LOAD PROFILE TEMPERATURE; AND 6) USE OF FACTORYWORKS RELEASE 7.11 MANUFACTURING SOFTWARE. |