PMA P190008S035

Device: IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Applicant: Medtronic Vascular, Inc.
PMA number: P190008
Supplement: S035
Product code: PRC
Decision date: 2024-11-22
Classification: Cardiovascular
Generic name: Drug-coated peripheral transluminal angioplasty catheter
Approval order statement: a modified reserve sampling approach for the IN.PACT AV DCB and IN.PACT 018 DCB, and a modified sampling plan for the IN.PACT 018 DCB drug content uniformity testing at lot release

Current openFDA PMA Record#

Device: IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Applicant: Medtronic Vascular, Inc.
PMA number: P190008
Supplement: S035
Product code: PRC
Generic name: Drug-coated peripheral transluminal angioplasty catheter
Decision date: 2024-11-22
Decision code: OK30
Date received: 2024-10-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a modified reserve sampling approach for the IN.PACT AV DCB and IN.PACT 018 DCB, and a modified sampling plan for the IN.PACT 018 DCB drug content uniformity testing at lot release