PMA P810046S196

Device: ACS RX COMET VP CORONARY DILATATION CATHETER (OTHER DILATATION CATHETERS)
Applicant: Advanced Cardiovascular Systems, Inc.
PMA number: P810046
Supplement: S196
Product code: LOX
Decision date: 1999-01-22
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: Approval for the implementation of an additional quality control inspection to further ensure that hte balloon size designation on the proximal adaptor is correct fo rthe ACS RX Comet VP(TM) Coronary Dilatation Catheter and the other ACS Coronary Dilatation Catheters listed in the supplement.

Current openFDA PMA Record#

Device: ACS RX COMET VP CORONARY DILATATION CATHETER (OTHER DILATATION CATHETERS)
Applicant: Advanced Cardiovascular Systems, Inc.
PMA number: P810046
Supplement: S196
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 1999-01-22
Decision code: APPR
Date received: 1998-12-22
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the implementation of an additional quality control inspection to further ensure that hte balloon size designation on the proximal adaptor is correct fo rthe ACS RX Comet VP(TM) Coronary Dilatation Catheter and the other ACS Coronary Dilatation Catheters listed in the supplement.