PMA P190008S019
- Device
- IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P190008
- Supplement
- S019
- Product code
- PRC
- Decision date
- 2022-07-08
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Approval order statement
- Additional controls be added to the luer inspection and gluing processes.
Current openFDA PMA Record#
- Device
- IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P190008
- Supplement
- S019
- Product code
- PRC
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Decision date
- 2022-07-08
- Decision code
- OK30
- Date received
- 2022-06-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional controls be added to the luer inspection and gluing processes.