PMA P810046S174
- Device
- ACS TX2000 VP CORONARY DILITATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S174
- Product code
- LOX
- Decision date
- 1997-06-11
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THELABELING OF THE ACS RX COMET(TM) CORONARY DILATATION CATHER AND ACS TX2000(TM) CORONARY DILATATION CATHETER.
Current openFDA PMA Record#
- Device
- ACS TX2000 VP CORONARY DILITATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S174
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1997-06-11
- Decision code
- APPR
- Date received
- 1997-02-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THELABELING OF THE ACS RX COMET(TM) CORONARY DILATATION CATHER AND ACS TX2000(TM) CORONARY DILATATION CATHETER.