PMA P190008S033
- Device
- IN.PACT AV DCB
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P190008
- Supplement
- S033
- Product code
- PRC
- Decision date
- 2024-12-03
- Classification
- Cardiovascular
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Approval order statement
- approval for an alternate active pharmaceutical ingredient formulation
Current openFDA PMA Record#
- Device
- IN.PACT AV DCB
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P190008
- Supplement
- S033
- Product code
- PRC
- Generic name
- Drug-coated peripheral transluminal angioplasty catheter
- Decision date
- 2024-12-03
- Decision code
- APPR
- Date received
- 2024-09-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for an alternate active pharmaceutical ingredient formulation