FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Stent, Coronary
PMA: P150039
·
Supplement: S003
·
Decision Mar 28, 2018
Classifications
1
FEI Numbers
28
Registration Numbers
28
Basic Information
- Device Name
- Stent, Coronary
- Trade Name
- TRYTON Side Branch Stent
- PMA Number
- P150039
- Supplement Number
- S003
- 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
- March 28, 2018
- Date Received
- September 29, 2017
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Labeling Change - PAS
- Expedited Review
- N
Advisory Committee Statement
Approval for updates to the labeling to include complete follow-up for the Pivotal RCT and EA Confirmatory Studies.
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 |