|
Device | RF CONTACTR |
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 | S047 |
Date Received | 12/18/2014 |
Decision Date | 03/05/2015 |
Product Code |
LPB |
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 REVISED SPECIFICATION, MANUFACTURING INSPECTION CRITERIA AND ASSOCIATED MEASUREMENT FIXTURE FOR THE IN-PROCESS INSPECTION OF THE DISTAL CURVE RANGE OF THE RF CONTACTR ABLATION CATHETERS. |