ACS CONCORDE CORONARY DILATATION CATHETER (QUARTER SIZE DIAMETER 30MM AND 40MM BALLON LENGTHS)
FDA premarket approval P810046/S167 · decided 1997-01-08
Approval details
- PMA number
- P810046
- Supplement
- S167
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACS CONCORDE CORONARY DILATATION CATHETER (QUARTER SIZE DIAMETER 30MM AND 40MM BALLON LENGTHS)
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 1996-07-09
- Decision date
- 1997-01-08
- Days to decision
- 183 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR THE ACS CONCORDE(TM) CORONARY DILATATION CATHETER WITH QUARTER SIZE DIAMETERS IN THE 30 MM AND 40 MM BALLOON LENGTHS, A CHANGE IN THE PROXIMAL CATHETER MARKING MATERIAL AND CHANGES TOT HE MANUFACTURING PROCESS.
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