LACROSSE/WRAP*PTCA CATHETERS;CHAMPION NC/WRAP NC PTCA CATHETER PRODUCT LINES
FDA premarket approval P930012/S011 · decided 1998-09-02
Approval details
- PMA number
- P930012
- Supplement
- S011
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LACROSSE/WRAP*PTCA CATHETERS;CHAMPION NC/WRAP NC PTCA CATHETER PRODUCT LINES
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Progressive Angioplasty Systems, Inc.
- Date received
- 1998-08-03
- Decision date
- 1998-09-02
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- Approval for modifications to the Y-adapter, packaging and labeling of the LaCrosse(TM) PTCA Catheter, Wrap(TM) PTCA Cathter, Champion(TM) NC PTCA Catheter and Wrap(TM) NC PTCA Catheter product lines.
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