- Device
- FACT(TM)AND ARC BALLOON CORNARY DILATATION CATHETERS
- Applicant
- Abbott Vascular Devices
- PMA number
- P910031
- Supplement
- S010
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1996-12-02
- Decision code
- APPR
- Date received
- 1996-07-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODELS OF THE FACT(TM) AND ARC(TM) BALLOON CORONARY DILATATIN CATHETERS WITH AN ADD'L RADIOPAQUE MARKER