|
Device | IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 Paclitax |
Generic Name | Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Applicant | MEDTRONIC Inc. 3576 UNOCAL PL SANTA ROSA, CA 95403 |
PMA Number | P140010 |
Date Received | 05/29/2014 |
Decision Date | 12/30/2014 |
Product Code |
ONU |
Docket Number | 15M-0199 |
Notice Date | 01/20/2015 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01566461
|
Expedited Review Granted? | Yes |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement FOR THE IN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER. THIS DEVICE IS INDICATED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, AFTER PREDILATATION, OF DE NOVO OR RESTENOTIC LESIONS UP TO 180 MM IN LENGTH IN NATIVE SUPERFICIAL FEMORAL OR POPLITEAL ARTERIES WITH REFERENCE VESSEL DIAMETERS OF 4-7 MM. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S011 S012 S001 S002 S003 S018 S019 S021 S022 S023 S024 S028 S031 S007 S009 S004 S005 S013 S010 S006 S025 S026 S014 S015 S016 S017 S034 S035 S036 S020 S029 S030 S027 S032 S033 S039 S046 S047 S050 S044 S045 S058 S059 S071 S062 S063 S054 S055 S072 S075 S037 S041 S048 S049 S052 S042 S043 S051 S067 S068 S061 S073 S056 S070 S064 S066 S060 S053 S077 S078 S074 S076 |