CROSSSAIL/OPENSAIL CORONARY DILATATION CATHETER
FDA premarket approval P810046/S201 · decided 2000-06-05
Approval details
- PMA number
- P810046
- Supplement
- S201
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CROSSSAIL/OPENSAIL CORONARY DILATATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 2000-02-28
- Decision date
- 2000-06-05
- Days to decision
- 98 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR THE CROSSSAIL AND OPENSAIL CORONARY DILATION CATHETERS. THESE CATHETERS ARE INDICATED FOR: (A) BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION AND (B) BALLOON DILATATION OF A CORONARY ARTERY OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.