|
Device | MEDTRONIC ENHANCER ABLATION CATHETERS |
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 | S019 |
Date Received | 12/16/2002 |
Decision Date | 01/08/2003 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING PROCESS CHANGE TO ADD AN ADDITIONAL QUALITY CONTROL INSPECTION. |