FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Stent, Coronary
PMA: P110004
·
Supplement: S021
·
Decision Feb 10, 2017
Classifications
1
FEI Numbers
28
Registration Numbers
28
Basic Information
- Device Name
- Stent, Coronary
- Trade Name
- NIRXCELL PMS US STUDY NIRTRAKS
- PMA Number
- P110004
- Supplement Number
- S021
- Device Class
- FDA Class 3
- Product Code
- MAF
- Generic Name
- STENT, CORONARY
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- February 10, 2017
- Date Received
- December 5, 2016
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol - OSB
- Expedited Review
- N
Advisory Committee Statement
Approval for cessation of patient enrollment in this PAS for the post-approval study (PAS).
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 |
|---|---|---|---|
| MAF | Stent, Coronary | FDA class 3 | Unknown |