- Device
- ORACLE(TM) CORONARY BALLOON DILATATION CATHETER
- Applicant
- Abbott Vascular Devices
- PMA number
- P910031
- Supplement
- S002
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1995-10-03
- Decision code
- APPR
- Date received
- 1995-03-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE FACT BALLOON CORONARY DILATATION CATHETER MARKETED UNDER TRADE NAME FACT BALLOON CORONARY DILATATION CATHETER