Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
• Generic Name: Drug-coated peripheral transluminal angioplasty catheter
• Applicant: Medtronic Vascular, Inc.; 3576 Unocal Place; Santa Rosa, CA 95403
• PMA Number: P190008
• Date Received: 04/03/2019
• Decision Date: 11/21/2019
• Product Code: PRC
• Docket Number: 19M-5534
• Notice Date: 11/22/2019
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No
• Recalls: CDRH Recalls

Approval Order Statement  
Approval for the IN.PACT AV Paclitaxel-coated PTA Balloon Catheter. The device is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, for the treatment of obstructive lesions up to 100 mm in length in the native arteriovenous dialysis fistulae with reference vessel diameters of 4 to 12 mm.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2
• Post-Approval Study: Show Report Schedule and Study Progress
• Supplements: S003 S004 S001 S006 S007 S011 S013 S018 S020 S021 S033 S038 ; S039 S044 S045 S029 S030 S036 S037 S027 S028 S005 S008 ; S002 S014 S015 S022 S019 S009 S010 S023 S024 S017 S016 S025 ; S026 S040 S041 S042 S043 S034 S035 S046