ACS RX STREAK & ACS FLOW TRACK 40
FDA premarket approval P810046/S162 · decided 1996-11-05
Approval details
- PMA number
- P810046
- Supplement
- S162
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ACS RX STREAK & ACS FLOW TRACK 40
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 1996-04-16
- Decision date
- 1996-11-05
- Days to decision
- 203 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR THE ADDITION OF NEW PRODUCT NAMES TO ALLOW CONCURRENT DISTRIBUTIO BY A SECOND COMPANY. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ACS RX GAZELLE CORONARY DILATATION CATHETER AND ACS RX FLEXFLO CORONARY DILATATION CATHETER
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