- Device
- IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, CoreValve EnVeo R Delivery Catheter
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P190008
- Supplement
- S027
- Product code
- PRC
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Decision date
- 2023-10-12
- Decision code
- OK30
- Date received
- 2023-09-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- removal of operators’ hands/gloves testing from the environmental monitoring program for all devices, manufactured at Medtronic Ireland in controlled environment areas meeting ISO Class 8 requirements