PMA P190008S029
- Device
- IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P190008
- Supplement
- S029
- Product code
- PRC
- Decision date
- 2024-05-08
- Classification
- Cardiovascular
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Approval order statement
- a reduction of cleanroom environmental monitoring testing locations
Current openFDA PMA Record#
- Device
- IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P190008
- Supplement
- S029
- Product code
- PRC
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Decision date
- 2024-05-08
- Decision code
- OK30
- Date received
- 2024-04-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a reduction of cleanroom environmental monitoring testing locations