|
Device | FLEXABILITY ABLATION CATHETER |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Abbott Medical 2375 MORSE AVENUE Plymouth, MN 55442 |
PMA Number | P110016 |
Supplement Number | S016 |
Date Received | 02/05/2015 |
Decision Date | 07/02/2015 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT SYNERGY HEALTH, IN ALAJUELA, COSTA RICA |