LACROSSE PTCA CATHETER/CHAMPION PTCA CATHETER PRODUCT LINE

FDA Premarket Approval P930012 S012

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for a change in labeling for the lacrosse(tm) ptca and champion(tm) ptca catheter product lines. Specifically, the change included a reduction in the labeled rated burst pressures for the 2. 5mmx20mm, 3. 0mmx30mm, and 3. 5mmx30mm lacrosse(tm) ptca catheters and the 2. 0mmx20mm champion(tm) ptca catheter.

DeviceLACROSSE PTCA CATHETER/CHAMPION PTCA CATHETER PRODUCT LINE
Generic NameCatheters, Transluminal Coronary Angioplasty, Percutaneous
ApplicantPROGRESSIVE ANGIOPLASTY SYSTEMS, INC.
Date Received1998-07-24
Decision Date1998-08-25
PMAP930012
SupplementS012
Product CodeLOX 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address PROGRESSIVE ANGIOPLASTY SYSTEMS, INC. 1350 Willow Rd. Suite 201 menlo Park, CA 94025

Supplemental Filings

Supplement NumberDateSupplement Type
P930012Original Filing
S012 1998-07-24 Normal 180 Day Track
S011 1998-08-03 Real-time Process
S010 1998-05-08 Real-time Process
S009 1998-01-08 Real-time Process
S008 1997-08-19 Normal 180 Day Track
S007
S006 1997-03-06 Normal 180 Day Track
S005 1996-08-01 Normal 180 Day Track
S004 1996-06-27 Normal 180 Day Track
S003 1995-11-13 Normal 180 Day Track
S002 1995-10-04 Normal 180 Day Track
S001 1995-10-04 Normal 180 Day Track

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