PMA P910031S016
- Device
- ORACLE MEGASONICS FIVE-64 PTCA CATHETER
- Applicant
- Abbott Vascular Devices
- PMA number
- P910031
- Supplement
- S016
- Product code
- LOX
- Decision date
- 1997-06-27
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- APPROVAL FOR THE ADDITION OF THE 30 MM BALLOON LENGTH TO THE ARC(TM) BALLOON CORONARY DILATATION CATHETERS.
Current openFDA PMA Record#
- Device
- ORACLE MEGASONICS FIVE-64 PTCA CATHETER
- Applicant
- Abbott Vascular Devices
- PMA number
- P910031
- Supplement
- S016
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1997-06-27
- Decision code
- APPR
- Date received
- 1997-05-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ADDITION OF THE 30 MM BALLOON LENGTH TO THE ARC(TM) BALLOON CORONARY DILATATION CATHETERS.