|
Device | ATAKR RFCA SYSTEM |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P930029 |
Supplement Number | S005 |
Date Received | 09/25/1995 |
Decision Date | 06/11/1996 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF THE RF PERFORMER SERIES OF CARDIAC ABLATION CATHETERS FOR THE ATAKR RFCA SYSTEM |