PMA P910031S009
- Device
- FACT(TM)AND ARC BALLOON CORNARY DILATATION CATHETERS
- Applicant
- Abbott Vascular Devices
- PMA number
- P910031
- Supplement
- S009
- Product code
- LOX
- Decision date
- 1996-08-20
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- APPROVAL FOR THE 22 MM MODELS OF THE FACT AND ARC BALLOON CORONARY DILATATION CATHETERS
Current openFDA PMA Record#
- Device
- FACT(TM)AND ARC BALLOON CORNARY DILATATION CATHETERS
- Applicant
- Abbott Vascular Devices
- PMA number
- P910031
- Supplement
- S009
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1996-08-20
- Decision code
- APPR
- Date received
- 1996-05-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE 22 MM MODELS OF THE FACT AND ARC BALLOON CORONARY DILATATION CATHETERS