PMA P810046S208
- Device
- CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S208
- Product code
- LOX
- Decision date
- 2001-06-05
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- APPROVAL FOR MODIFICATIONS OF WHITE FOIL MARKERS IN THE POWERSAIL(TM), HIGHSAIL(TM), CROSSSAIL(TM), OPENSAIL(TM), AND ACS ESPRIT PTCA CATHETERS.
Current openFDA PMA Record#
- Device
- CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S208
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2001-06-05
- Decision code
- APPR
- Date received
- 2001-05-10
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS OF WHITE FOIL MARKERS IN THE POWERSAIL(TM), HIGHSAIL(TM), CROSSSAIL(TM), OPENSAIL(TM), AND ACS ESPRIT PTCA CATHETERS.