PMA P190008S037
- Device
- IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P190008
- Supplement
- S037
- Product code
- PRC
- Decision date
- 2025-01-24
- Classification
- Cardiovascular
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Approval order statement
- approval for an additional inspection at a supplier.
Current openFDA PMA Record#
- Device
- IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P190008
- Supplement
- S037
- Product code
- PRC
- Generic name
- Drug-coated 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.