EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM
FDA premarket approval P060006/S070 · decided 2015-10-23
Approval details
- PMA number
- P060006
- Supplement
- S070
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM
- Generic name
- STENT, RENAL
- Applicant
- Boston Scientific Corp
- Date received
- 2015-09-02
- Decision date
- 2015-10-23
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- NIN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR LABELING CHANGES REGARDING MAGNETIC RESONANCE COMPATIBILITY AND REMOVAL OF THE FLUSHING NEEDLE FROM THE PRODUCT PACKAGING.
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|---|---|---|
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| XXL Vascular Balloon Dilatation Catheter (K150303) | Boston Scientific Corp | 2015-06-15 |
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| EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679) | Boston Scientific Corp | 2015-05-29 |
| JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820) | Boston Scientific Corp | 2014-10-21 |