|
Device | INSYNC/INSYNC III CRT-IPGS |
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 | S025 |
Date Received | 10/17/2006 |
Decision Date | 11/15/2006 |
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 | Yes |
Approval Order Statement REDUCTION IN THE NUMBER OF SEAMWELD PENETRATION MONITORING SAMPLES AND A MINOR MODIFICATION IN PROCESSING OF SEAMWELD DATA. |