ACS RX COMET CORONARY DILATION CATHETER
FDA premarket approval P810046/S171 · decided 1997-05-12
Approval details
- PMA number
- P810046
- Supplement
- S171
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACS RX COMET CORONARY DILATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 1996-12-23
- Decision date
- 1997-05-12
- Days to decision
- 140 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR THE ACS RX COMET(TM) CORONARY DILATATION CATHETER WITH THE 40 MM BALLOON LENGTHS WITH THE HALF SIZES (I.E., 2.0 MM, 2.5 MM, 3.0 MM, 3.5 MM, 4.0 MM), THE 15 MM BALLOON LENGTHS WITH THE QUARTER SIZES (I.E., 2.75 MM, 3.25 MM AND 3.75 MM DIAMETERS), THE 30 MM BALLOON LENGTHS (I.E., 2.75 MM, 3.25 MM, 3.75 MM AND 4.0 MM DIAMETERS) AND A SINGLE 20 MM BALLOON LENGTH (I.E., 1.5 MM) AND MODIFICATION OF THE BALLOON COMPLIANCE CHART OF THE ACS RX COMET(TM) CORONARY DILATATION CATHETER TO INLCUD
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