|
Device | INSYNC III MODEL 8042 ATRIAL SYNCHRONOUS BIVENTRICULAR PACING DEVICE |
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 | S009 |
Date Received | 03/05/2003 |
Decision Date | 03/27/2003 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC B.V., EUROPEAN OPERATIONS CENTER, HEERLEN, THE NETHERLANDS. FINAL DEVICE PACKAGING WILL BE PERFORMED AT THIS FACILITY. |
Post-Approval Study | Show Report Schedule and Study Progress |