PMA P190008S022
- Device
- IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P190008
- Supplement
- S022
- Product code
- PRC
- Decision date
- 2022-12-01
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Approval order statement
- Implement an alternative bacterial water testing method.
Current openFDA PMA Record#
- Device
- IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P190008
- Supplement
- S022
- Product code
- PRC
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Decision date
- 2022-12-01
- Decision code
- OK30
- Date received
- 2022-11-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement an alternative bacterial water testing method.