PMA P810046S200
- Device
- ACS RX/OTW SOLARIS CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S200
- Product code
- LOX
- Decision date
- 2000-02-16
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- A revision to the Instructions for Use booklet for ACS RX SOLARIS and ACS OTW SOLARIS Coronary Dilatation Catheters to include the addition fo the ACS Multi-Link Tristar Stent to the sections pertaining to post-implant stent dilatation.
Current openFDA PMA Record#
- Device
- ACS RX/OTW SOLARIS CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S200
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2000-02-16
- Decision code
- APPR
- Date received
- 2000-01-20
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- A revision to the Instructions for Use booklet for ACS RX SOLARIS and ACS OTW SOLARIS Coronary Dilatation Catheters to include the addition fo the ACS Multi-Link Tristar Stent to the sections pertaining to post-implant stent dilatation.