PMA P810046S157
- Device
- ACS SIMPSON-ROBERT CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S157
- Product code
- LOX
- Decision date
- 1995-12-05
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- APPROVAL FOR THE ACS OTW LIFESTREAM CORONARY DILATATION CATHETER
Current openFDA PMA Record#
- Device
- ACS SIMPSON-ROBERT CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S157
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1995-12-05
- Decision code
- APPR
- Date received
- 1995-09-14
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE ACS OTW LIFESTREAM CORONARY DILATATION CATHETER