|
Device | EXABLATE DEVICE |
Generic Name | Ablation system, high intensity focused ultrasound (HIFU), MR-guided |
Applicant | INSIGHTEC, LTD 4851 LBJ FRWY, STE 400 DALLAS, TX 75244 |
PMA Number | P040003 |
Supplement Number | S011 |
Date Received | 04/09/2012 |
Decision Date | 05/01/2012 |
Product Code |
NRZ |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR LABELING CHANGES INCLUDING: 1) DELETION OF THE COMMENT (OUTCOMES OF 10 PREGNANCIES ARE PENDING AS OF AUGUST 2008, AND OUTCOME OF ONE PREGNANCY IS UNKNOWN.) AND ADDITION OF DEEP VEIN THROMBOSIS UNDER THE SECTION ENTITLED OTHER ADVERSE EVENTS. |
Post-Approval Study | Show Report Schedule and Study Progress |