- Device
- IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P190008
- Supplement
- S030
- Product code
- PRC
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Decision date
- 2024-06-27
- Decision code
- OK30
- Date received
- 2024-05-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the addition of a manufacturing line for the the primary packaging of the IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter, IN.PACT AV Paclitaxel-Coated PTA Balloon Catheter and IN.PACT 018 Paclitaxel-Coated PTA Balloon Catheter