FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM
FDA premarket approval P890043/S037 · decided 2001-12-05
Approval details
- PMA number
- P890043
- Supplement
- S037
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM
- Generic name
- CATHETER, CORONARY, ATHERECTOMY
- Applicant
- Abbott Vascular
- Date received
- 2001-06-07
- Decision date
- 2001-12-05
- Days to decision
- 181 days
- Decision code
- APPR
- Product code
- MCX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR LABELING CHANGES FOR THE FLEXI-CUT(TM) DIRECTIONAL DEBULKING SYSTEM. THE LABELING CHANGES INCLUDE THE ADDITION OF A SUMMARY OF THE PHYSICIAN PREFERENCE TESTING INFORMATION, AND THE ADDITION OF A WARNING STATEMENT TO REMOVE ATHEROMATOUS TISSUE FROM THE NOSECONE FREQUENTLY TO AVOID GUIDEWIRE RESTRICTION.
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