PMA P810046S180
- Device
- ACS RX COMET CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S180
- Product code
- LOX
- Decision date
- 1997-08-12
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- APPROVAL FOR MODIFICATION TO THE INSTRUCTIONS FOR USE.
Current openFDA PMA Record#
- Device
- ACS RX COMET CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S180
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1997-08-12
- Decision code
- APPR
- Date received
- 1997-07-01
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MODIFICATION TO THE INSTRUCTIONS FOR USE.