|
Device | LIVEWIRE TC AND SAFIRE ABLATION CATHETERS |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | St. Jude Medical 14900 MINNETONKA IND RD MINNETONKA, MN 55345 |
PMA Number | P960016 |
Supplement Number | S048 |
Date Received | 08/06/2014 |
Decision Date | 09/05/2014 |
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 ADDITION OF A NEW INSPECTION STEP TO THE PACKAGE SEALING AND STERILE PACKAGE ASSEMBLY MANUFACTURING PROCEDURES AND ADDITIONAL CLARIFICATIONS TO FINAL PACKAGE INSPECTION FOR SPECIFIC VISUAL INSPECTION PROCEDURE, INCLUDING AN INSPECTION STEP FOR DETECTING WRINKLES. |