|
Device | MEDTRONIC MODEL 4193 ATTAIN OTW LEAD |
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 | S010 |
Date Received | 04/08/2003 |
Decision Date | 05/09/2003 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MATERIAL AND LABELING CHANGES FOR VARIOUS MEDTRONIC AND VITATRON PACING AND DEFIBRILLATOR LEADS. |