PMA P810046S173
- Device
- TX-2000
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S173
- Product code
- LOX
- Decision date
- 1997-04-21
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- APPROVAL FOR THE ACS TX2000(TM) CORONARY DILATATION CATHETER WITH NEW BALLOON LENGTHS (15 MM AND 40 MM), ADDITIONAL BALLOON DIAMETERS FOR THE 20 MM AND 30 MM BALLOON LENGTHS, AND REVISED LABELING.
Current openFDA PMA Record#
- Device
- TX-2000
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S173
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1997-04-21
- Decision code
- APPR
- Date received
- 1997-01-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ACS TX2000(TM) CORONARY DILATATION CATHETER WITH NEW BALLOON LENGTHS (15 MM AND 40 MM), ADDITIONAL BALLOON DIAMETERS FOR THE 20 MM AND 30 MM BALLOON LENGTHS, AND REVISED LABELING.