GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM) 12MM LONG
FDA premarket approval P910030/S005 · decided 1997-05-12
Approval details
- PMA number
- P910030
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM) 12MM LONG
- Generic name
- STENT, CORONARY
- Applicant
- Cook, Inc.
- Date received
- 1996-11-26
- Decision date
- 1997-05-12
- Days to decision
- 167 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bloomington, IN
- Statement
- APPROVAL FOR A MODIFIED VERSION OF THE ORIGINAL GIANTURCO-ROUBIN CORONARY FLEX STENT(TM). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GR II(TM) CORONARY STENT AND IS INDICATED FOR TREATMENT OF ACUTE OR THREATENED CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN VESSELS WITH REFERENCE DIAMETERS IN THE RANGE OF 2.1 MM TO 4.0 MM.
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