NC STORMER MX2/OTW BALLOON DILATATION CATHETER
FDA premarket approval P790017/S082 · decided 2005-03-04
Approval details
- PMA number
- P790017
- Supplement
- S082
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NC STORMER MX2/OTW BALLOON DILATATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Medtronic, Ireland
- Date received
- 2004-04-05
- Decision date
- 2005-03-04
- Days to decision
- 333 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- APPROVAL FOR ADDITION OF THE NC STORMER MX2 CATHETER WITH TWO ADDITIONAL LENGTHS (AS A MODIFIED VERSION OF THE APPROVED NC STORMER MX CATHETER) AND THE ADDITION OF TWO ADDITIONAL LENGTHS FOR THE NC STORMER OTW CATHETER.
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