PMA P910031S019
- Device
- THE ORACLE MEGASONICS FIVE-64 PTCA CATHER
- Applicant
- Abbott Vascular Devices
- PMA number
- P910031
- Supplement
- S019
- Product code
- LOX
- Decision date
- 1998-12-11
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- Approval for modifications to the Endosonics Oracle MegaSonics Five-64(TM) PTCA Catheter.
Current openFDA PMA Record#
- Device
- THE ORACLE MEGASONICS FIVE-64 PTCA CATHER
- Applicant
- Abbott Vascular Devices
- PMA number
- P910031
- Supplement
- S019
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1998-12-11
- Decision code
- APPR
- Date received
- 1998-06-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for modifications to the Endosonics Oracle MegaSonics Five-64(TM) PTCA Catheter.