|
Device | DISPOSABLE EPG COVER; DUAL CHAMBER TEMPORARY PACEMANKER; SINGLE CHAMBER TEMPORARY PACEMAKER |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P820003 |
Supplement Number | S126 |
Date Received | 12/19/2013 |
Decision Date | 01/16/2014 |
Product Code |
LWP |
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 RELOCATION FOR THE PERFORMANCE OF SELECTED INSPECTION ACTIVITIES USED FOR INCOMING/RECEIVING FOR SELECTED MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT (CRDM) PRODUCTS. |