FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM
FDA premarket approval P890043/S035 · decided 2001-04-06
Approval details
- PMA number
- P890043
- Supplement
- S035
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Abbott Vascular
- Date received
- 2000-03-06
- Decision date
- 2001-04-06
- Days to decision
- 396 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR THE FLEXI-CUT(TM) DIRECTION DEBULKING SYSTEM. THE FLEXI-CUT(TM) DIRECTION DEBULKING SYSTEM IS INDICATED FOR USE IN CORONARY ARTERY DISEASE ACCESSIBLE TO DCA (DIRECTIONAL CORONARY ATHERECTOMY), GENERALLY IN THE PROXIMAL OR MID-PORTION OF CORONARY VESSELS. IT CAN BE USED ALONE OR IN CONJUNCTION WITH OTHER CORONARY INTERVENTIONAL DEVICES. DCA IS INTENDED TO IMPROVE CORONARY LUMINAL DIAMETER BY MECHANICALLY SHAVING AND REMOVING ATHEROSCLEROTIC MATERIAL FROM THE DISEASED VESSEL.
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