|
Device | SAFIRE BLU DUO ABLATION CATHETERS |
Generic Name | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
Applicant | Abbott Medical 2375 MORSE AVENUE Plymouth, MN 55442 |
PMA Number | P110016 |
Supplement Number | S005 |
Date Received | 07/11/2012 |
Decision Date | 11/29/2012 |
Product Code |
OAD |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00984204
|
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ALTERNATE SUPPLIER OF THE CATHETER SHAFT SUBASSEMBLY. |