INTEGRITY CORONARY STENT SYSTEM
FDA premarket approval P030009/S039 · decided 2010-09-14
Approval details
- PMA number
- P030009
- Supplement
- S039
- Supplement type
- Normal 180 Day Track
- Trade name
- INTEGRITY CORONARY STENT SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Medtronic, Ireland
- Date received
- 2010-02-12
- Decision date
- 2010-09-14
- Days to decision
- 214 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Galway
- Statement
- APPROVAL FOR THE INTEGRITY CORONARY STENT SYSTEM. THE DEVICE IS INDICATED FOR IMPROVINGCORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC LESIONS, WITH REFERENCE VESSEL DIAMETERS OF 2.25-4.0 MM AND <=30 MM IN LENGTH, USING DIRECT STENTING OR PREDILATATION.
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