LACROSSE PTCA CATHETER/CHAMPION PTCA CATHETER PRODUCT LINE
FDA premarket approval P930012/S012 · decided 1998-08-25
Approval details
- PMA number
- P930012
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LACROSSE PTCA CATHETER/CHAMPION PTCA CATHETER PRODUCT LINE
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Progressive Angioplasty Systems, Inc.
- Date received
- 1998-07-24
- Decision date
- 1998-08-25
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- 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.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.