PMA P140010S088

Device: IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon, IN.PACT 018 Paclitaxel-Coated Per
Applicant: Medtronic, Inc.
PMA number: P140010
Supplement: S088
Product code: ONU
Decision date: 2025-01-24
Classification: Cardiovascular
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Approval order statement: approval for an additional inspection at a supplier.

Current openFDA PMA Record#

Device: IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon, IN.PACT 018 Paclitaxel-Coated Per
Applicant: Medtronic, Inc.
PMA number: P140010
Supplement: S088
Product code: ONU
Generic name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Decision date: 2025-01-24
Decision code: APPR
Date received: 2025-01-07
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for an additional inspection at a supplier.