SIMPSON-ROBERT PTCA CATHETER ACS RX LIFESTREAM AND ACS OTW LIFESTREAM PTCA CATHETERS
FDA premarket approval P810046/S160 · decided 1995-12-28
Approval details
- PMA number
- P810046
- Supplement
- S160
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SIMPSON-ROBERT PTCA CATHETER ACS RX LIFESTREAM AND ACS OTW LIFESTREAM PTCA CATHETERS
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 1995-11-22
- Decision date
- 1995-12-28
- Days to decision
- 36 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR MODIFICATIONS OF THE INFLATION/DEFLATION NOTCH OF THE ABOVE CATHETERS AND CHANGES TO THE GUIDE WIRE EXIT NOTCH AND PROXIMAL ADATPION VISUAL INSPECTIN CRITERIA OF THE RX LIFESTREAM CATHETER
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