VOYAGER RX CORONARY DILATATION CATHETER
FDA premarket approval P810046/S216 · decided 2004-06-18
Approval details
- PMA number
- P810046
- Supplement
- S216
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VOYAGER RX CORONARY DILATATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 2004-03-08
- Decision date
- 2004-06-18
- Days to decision
- 102 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR THE VOYAGER RX CORONARY DILATATION CATHETER. THE DEVICE, AS MODIFIED, IS INDICATED FOR 1) BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION, 2) BALLOON DILATATION OF A CORONARY OCCLUSION FOR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION, AND 3) BALLOON DILATATION OF STENT AFTER IMPLANTATION (TESTING INCLUDING THE FOLLOWING GUIDANT STENTS: MULT
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