FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Drug-Coated Peripheral Transluminal Angioplasty Catheter
PMA: P170003
·
Supplement: S025
·
Decision Dec 2, 2021
Classifications
1
FEI Numbers
7
Registration Numbers
7
Basic Information
- Device Name
- Drug-Coated Peripheral Transluminal Angioplasty Catheter
- Trade Name
- Lutonix 018
- PMA Number
- P170003
- Supplement Number
- S025
- Device Class
- FDA Class 3
- Product Code
- PRC
- Generic Name
- Drug-coated peripheral transluminal angioplasty catheter
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- December 2, 2021
- Date Received
- November 18, 2021
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Removal of a process documentation step for the vacuum drying process when no deviations from process parameters are identified during the automated cycle, to reduce redundancy.
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 |