PMA P810046S167
- Device
- ACS CONCORDE CORONARY DILATATION CATHETER (QUARTER SIZE DIAMETER 30MM AND 40MM BALLON LENGTHS)
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S167
- Product code
- LOX
- Decision date
- 1997-01-08
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order 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.
Current openFDA PMA Record#
- Device
- ACS CONCORDE CORONARY DILATATION CATHETER (QUARTER SIZE DIAMETER 30MM AND 40MM BALLON LENGTHS)
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S167
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1997-01-08
- Decision code
- APPR
- Date received
- 1996-07-09
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.