- Device
- IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P190008
- Supplement
- S038
- Product code
- PRC
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Decision date
- 2026-01-30
- Decision code
- APPR
- Date received
- 2025-04-07
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a visual system with a reticulate as a manufacturing aid during the catheter subassembly welding manufacturing step to aid in ensuring proper overlap between two of the device components