TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA premarket approval P060008/S008 · decided 2009-05-21
Approval details
- PMA number
- P060008
- Supplement
- S008
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Boston Scientific Corp
- Date received
- 2008-11-28
- Decision date
- 2009-05-21
- Days to decision
- 174 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL TO EXPAND THE PRODUCT MATRIX TO INCLUDE THE 2.25 MM TAXUSLIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM. THIS DEVICE SIZE WILL BE MARKETED UNDER THETRADE NAME TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS), AND IS INDICATED FOR IMPROVING LUMINAL DIAMETER FOR THETREATMENT OF DE NOVO LESIONS IN NATIVE CORONARY ARTERIES > =2.25 MM TO <= 4.00 MM IN DIAMETER INLESIONS <= 28 MM IN LENGTH.
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