MEDTRONIC VASCULAR NC STORMER MX2 BALLON DILATATION CATHETER
FDA premarket approval P790017/S085 · decided 2006-05-12
Approval details
- PMA number
- P790017
- Supplement
- S085
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MEDTRONIC VASCULAR NC STORMER MX2 BALLON DILATATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Medtronic, Ireland
- Date received
- 2006-04-17
- Decision date
- 2006-05-12
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- APPROVAL FOR UPDATES TO THE INSTRUCTIONS FOR USE (IFU) IN ORDER TO ENHANCE THE SAFETY OF THE DEVICE AND AVOID THE GUIDEWIRE EXITING THE GUIDE WAY OF THE CATHETER.
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