|
Device | THERAPY COOL PATH DUO ABLATION CATHETER AND THERAPY COOL FLEX ABLATION CATHETER |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Abbott Medical 2375 MORSE AVENUE Plymouth, MN 55442 |
PMA Number | P110016 |
Supplement Number | S017 |
Date Received | 04/20/2015 |
Decision Date | 05/20/2015 |
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 CHANGE IN MANUFACTURING ROOM LOCATION OF THE BAND ELECTRODE SUB-ASSEMBLY. |