PMA P190008S025
- Device
- IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P190008
- Supplement
- S025
- Product code
- PRC
- Decision date
- 2023-09-14
- Classification
- Cardiovascular
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P190008
- Supplement
- S025
- Product code
- PRC
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Decision date
- 2023-09-14
- Decision code
- APPR
- Date received
- 2023-08-17
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.