LIFESTAR VASCULAR STENT SYSTEMS
FDA premarket approval P080007/S007 · decided 2011-11-16
Approval details
- PMA number
- P080007
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LIFESTAR VASCULAR STENT SYSTEMS
- Generic name
- STENT, ILIAC
- Applicant
- Bard Peripheral Vascular, Inc.
- Date received
- 2011-09-26
- Decision date
- 2011-11-16
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tempe, AZ
- Statement
- APPROVAL FOR REMOVAL OF THE PCRFORMAXX GRIP ON THE DELIVERY SYSTEM, THE ADDITION OF A SMALLER PACKAGING CONFIGURATION, AND MINOR LABELING CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIFESTAR VASCULAR STENT SYSTEM AND IS INDICATED FOR THE TREATMENT OF ILIAC OCCLUSIVE DISEASE IN PATIENTS WITH SYMPTOMATIC VASCULAR DISEASE OF THE COMMON AND/OR EXTERNAL ILIAC ARTERIES UP TO 126 MM IN LENGTH WITH A REFERENCE VESSEL DIAMETER OF 5 TO 9 MM.
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