Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: IN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL BALLOON CATHETER
• Generic Name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
• Applicant: Medtronic, Inc.; 3576 Unocal Pl.; Santa Rosa, CA 95403
• PMA Number: P140010
• Supplement Number: S009
• Date Received: 07/21/2015
• Decision Date: 12/04/2015
• Product Code: ONU
• 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: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC MEXICO, TIJUANA, BAJA CALIFORNIA, MEXICO.