|
Device | INSYNC III CRT-P & INSYNC CRT-P |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P010015 |
Supplement Number | S057 |
Date Received | 11/20/2008 |
Decision Date | 12/17/2008 |
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 REDUCTION IN THE SAMPLING FREQUENCY OF ROUTINE ENVIRONMENTAL MONITORING IN THE CONTROLLED ENVIRONMENT ARE AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY IN JUNCOS, PUERTO RICO. |