|
Device | TRANSVENE CS/SVC LEAD |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET MS MVS11 MOUNDS VIEW, MN 55112 |
PMA Number | P980050 |
Supplement Number | S055 |
Date Received | 10/26/2010 |
Decision Date | 11/23/2010 |
Product Code |
LWS |
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. |