PMA P910031S012
- Device
- ARC(TM) BALLOON CORONARY DILATATION CATHETERS
- Applicant
- Abbott Vascular Devices
- PMA number
- P910031
- Supplement
- S012
- Product code
- LOX
- Decision date
- 1997-02-27
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- APPROVAL FOR THE ADDITION OF THE 2.0 MM BALLON SIZE TO THE ARC(TM) BALLOON CORONARY DILATATION CATHETERS
Current openFDA PMA Record#
- Device
- ARC(TM) BALLOON CORONARY DILATATION CATHETERS
- Applicant
- Abbott Vascular Devices
- PMA number
- P910031
- Supplement
- S012
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1997-02-27
- Decision code
- APPR
- Date received
- 1996-09-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ADDITION OF THE 2.0 MM BALLON SIZE TO THE ARC(TM) BALLOON CORONARY DILATATION CATHETERS