|
Device | MEDTRONIC.KAPPA 700/600 SERIES OF PACEMAKERS |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P980035 |
Supplement Number | S006 |
Date Received | 12/06/1999 |
Decision Date | 12/20/1999 |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement Approval for a correction to the shipping box label for the Model KDR 721 pacemaker properly identifying the contents as a "Dual Chamber Rate Responsive Pacemaker." |