NEXSTENT CAROTID STENT & MONORAIL DELIVERY SYSTEM
FDA premarket approval P050025/S007 · decided 2007-12-20
Approval details
- PMA number
- P050025
- Supplement
- S007
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NEXSTENT CAROTID STENT & MONORAIL DELIVERY SYSTEM
- Generic name
- Stent, carotid
- Applicant
- Boston Scientific
- Date received
- 2007-12-07
- Decision date
- 2007-12-20
- Days to decision
- 13 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR A LABELING CLARIFICATION FOR ?ARRYTHMIA?, THE ADDITION OF ?STENT FRACTURE? TO THE LIST OF POTENTIAL ADVERSE EVENTS, AND CLARIFICATIONS TO THE LABELING TO CLARIFY COMPLETE REMOVAL OF THE DELIVERY SYSTEM TRACKING TIP FROM GUIDE HEATH OR GUIDE CATHETER WHEN REMOVING THE DEVICE UNDER FLUOROSCOPY (ITEMS 11, 12, AND 17 OR TABLE 1).
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