TAKUMI OVER THE WIRE PTCA CATHETERS
FDA premarket approval P880027/S049 · decided 1997-11-10
Approval details
- PMA number
- P880027
- Supplement
- S049
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TAKUMI OVER THE WIRE PTCA CATHETERS
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Boston Scientific
- Date received
- 1997-05-12
- Decision date
- 1997-11-10
- Days to decision
- 182 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for a new model PTCA catheter. The device, as modified, will be marketed under the trade name Takumi(TM) Over the Wire Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
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