ACS CORONARY DILATATION CATHETERS (INDICATION)
FDA premarket approval P810046/S170 · decided 1997-05-13
Approval details
- PMA number
- P810046
- Supplement
- S170
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ACS CORONARY DILATATION CATHETERS (INDICATION)
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 1996-11-25
- Decision date
- 1997-05-13
- Days to decision
- 169 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- Yes
- Location
- Temecula, CA
- 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.
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