PMA P900043S036
Current openFDA PMA Record
- Device
- BX VELOCITY STENT WITH RAPTOR OVER-THE-WIRE DELIVERY SYSTEM, BX VELOCITY STENT ON RAPTORRAIL TX DELIVERY SYSTEM
- Applicant
- Cordis Corp.
- PMA number
- P900043
- Supplement
- S036
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2002-08-22
- Decision code
- APPR
- Date received
- 2002-02-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL TO AMEND THE LABELING (INSTRUCTIONS FOR USE) FOR THE DEVICES.