|
Device | RF /RF MARINR NTC/5F RF MARINR/RF CONDUCTR/RF ENHANCR II ABLATION/RF CONTACTR 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 | S028 |
Date Received | 11/12/2010 |
Decision Date | 12/08/2010 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement UPDATE TO SUPPLIER QUALITY SOFTWARE. |