PMA P810046S170
- Device
- ACS CORONARY DILATATION CATHETERS (INDICATION)
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S170
- Product code
- LOX
- Decision date
- 1997-05-13
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- APPROVAL FOR: A) THE ADDITION OF THE INDICATION "BALLOON DILATATION OF A CORONARY ARTERY OCCLUSION OFR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION"; AND (B) OTHER MODIFICATIONS OT THE CURRENT LABEL TO REFLECT THIS NEW INDICATION.
Current openFDA PMA Record#
- Device
- ACS CORONARY DILATATION CATHETERS (INDICATION)
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S170
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1997-05-13
- Decision code
- APPR
- Date received
- 1996-11-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR: A) THE ADDITION OF THE INDICATION "BALLOON DILATATION OF A CORONARY ARTERY OCCLUSION OFR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION"; AND (B) OTHER MODIFICATIONS OT THE CURRENT LABEL TO REFLECT THIS NEW INDICATION.