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Device | MEDTRONIC MODEL 7250 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (AF ONLY STUDY) |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET MS MVS11 MOUNDS VIEW, MN 55112 |
PMA Number | P980050 |
Supplement Number | S006 |
Date Received | 06/27/2001 |
Decision Date | 08/29/2001 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE POST-APPROVAL PROTOCOL FOR CONTINUED FOLLOW-UP OF THE PATIENTS WHO RECEIVED THE MODEL 7250 FOR THE AF ONLY INDICATION. |
Post-Approval Study | Show Report Schedule and Study Progress |