FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Stent, Carotid
PMA: P050019
·
Supplement: S006
·
Decision Dec 3, 2010
Classifications
1
FEI Numbers
24
Registration Numbers
24
Basic Information
- Device Name
- Stent, Carotid
- Trade Name
- CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS
- PMA Number
- P050019
- Supplement Number
- S006
- Device Class
- FDA Class 3
- Product Code
- NIM
- Generic Name
- Stent, carotid
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- December 3, 2010
- Date Received
- October 7, 2010
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol - OSB
- Expedited Review
- N
Advisory Committee Statement
APPROVAL OF THE POST APPROVAL STUDY PROTOCOL.
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 |
|---|---|---|---|
| NIM | Stent, Carotid | FDA class 3 | Unknown |