PMA P900043S024
- Device
- BX VELOCITY(TM) WITH HEPACOAT(TM) ON RAPTOR (TM) STENT SYSTEM FOR CORONARY ARTERIES
- Applicant
- Cordis Corp.
- PMA number
- P900043
- Supplement
- S024
- Product code
- MAF
- Decision date
- 2000-07-21
- Generic name
- STENT, CORONARY
- Approval order statement
- APPROVAL FOR THE ADDITION OF A HEPARIN COATING TO THE BX VELOCITY(TM) CORONARY STENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BX VELOCITY(TM) WITH HEPACOAT(TM) ON RAPTOR(TM) STENT SYSTEM AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE TREATMENT OF ABRUPT OR THREATENED VESSEL CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS (<= 30 MM IN LENGTH) WITH REFERENCE DIAMETERS IN THE RANGE OF 2.25 TO 4.00 MM.
Current openFDA PMA Record
- Device
- BX VELOCITY(TM) WITH HEPACOAT(TM) ON RAPTOR (TM) STENT SYSTEM FOR CORONARY ARTERIES
- Applicant
- Cordis Corp.
- PMA number
- P900043
- Supplement
- S024
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2000-07-21
- Decision code
- APPR
- Date received
- 2000-02-08
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ADDITION OF A HEPARIN COATING TO THE BX VELOCITY(TM) CORONARY STENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BX VELOCITY(TM) WITH HEPACOAT(TM) ON RAPTOR(TM) STENT SYSTEM AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE TREATMENT OF ABRUPT OR THREATENED VESSEL CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS (