PMA P190008S004
- Device
- IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P190008
- Supplement
- S004
- Product code
- PRC
- Decision date
- 2020-09-24
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Approval order statement
- Approval for a packaging change to the shelf carton.
Current openFDA PMA Record#
- Device
- IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P190008
- Supplement
- S004
- Product code
- PRC
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Decision date
- 2020-09-24
- Decision code
- APPR
- Date received
- 2020-06-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a packaging change to the shelf carton.