CROSS-SAIL(TM) AND OPENSAIL(TM) CORONARY DILATATION CATHETERS
FDA premarket approval P810046/S205 · decided 2001-01-24
Approval details
- PMA number
- P810046
- Supplement
- S205
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CROSS-SAIL(TM) AND OPENSAIL(TM) CORONARY DILATATION CATHETERS
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 2000-12-19
- Decision date
- 2001-01-24
- Days to decision
- 36 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR THE REVISION OF THE CROSSSAIL AND OPENSAIL CORONARY DILATATION CATHETER'S COMPLIANCE CHARTS. THESE CATHETERS ARE INDICATED FOR: 1) BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION AND 2) BALLOON DILATATION OF A CORONARY ARTERY OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION.
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