ACS RX COMET VP (TM) CORONARY DILATATION CATHETER/HYDROCOAT HYDROPHILIC
FDA premarket approval P810046/S185 · decided 1998-06-08
Approval details
- PMA number
- P810046
- Supplement
- S185
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACS RX COMET VP (TM) CORONARY DILATATION CATHETER/HYDROCOAT HYDROPHILIC
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 1998-01-20
- Decision date
- 1998-06-08
- Days to decision
- 139 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- Approval for an additional balloon length, the addition of HYDROCOAT(TM) hydrophilic coating, a change in the sterilization method and hydrophilic coating, a change in the sterilization method and hydrophilic coating, a change in the sterilization method and packaging and an increase in the rated ubrst pressure for the 3.25mm through 4.0mm balloon diameters. The device as modified, will be marketed under the trade name ACS RX Comet VP(TM) Coronary Dilatation Catheters with HYDROCOAT(TM) Hydrophi
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