FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Drug-Coated Peripheral Transluminal Angioplasty Catheter
PMA: P170003
·
Supplement: S014
·
Decision Nov 26, 2019
Classifications
1
FEI Numbers
7
Registration Numbers
7
Basic Information
- Device Name
- Drug-Coated Peripheral Transluminal Angioplasty Catheter
- Trade Name
- LUTONIX 035 Drug Coated Balloon PTA Catheter, Model 9010
- PMA Number
- P170003
- Supplement Number
- S014
- Device Class
- FDA Class 3
- Product Code
- PRC
- Generic Name
- Drug-coated peripheral transluminal angioplasty catheter
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 26, 2019
- Date Received
- October 3, 2019
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol
- Expedited Review
- N
Advisory Committee Statement
Approval for the revised protocol and informed consent for the New Enrollment PAS Registry.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PRC | Drug-Coated Peripheral Transluminal Angioplasty Catheter | FDA class 3 | Unknown |