|
Device | RF MARINR/NTC/5F RF MARINR/RF CONDUCTR/RF ENHANCR II ABLATION/RF CONTACTR/CONDUCTR SELF-REF/ATAKR II |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P930029 |
Supplement Number | S027 |
Date Received | 10/26/2010 |
Decision Date | 11/23/2010 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement IMPLEMENTATION OF AN UPDATED VERSION OF THE STATISTICAL PROCESS CONTROL (SPC) SOFTWARE SYSTEM ACROSS MULTIPLE MANUFACTURING LOCATIONS AND VERTICALLY INTEGRATED SUPPLIERS. |