ACS RX LIFESTREAM
FDA premarket approval P810046/S176 · decided 1997-07-17
Approval details
- PMA number
- P810046
- Supplement
- S176
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACS RX LIFESTREAM
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 1997-03-14
- Decision date
- 1997-07-17
- Days to decision
- 125 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- Approval for ACS RX LIFESTREAM(TM) Coronary Dilatation Catheter with 4.5 mm and 5.0 mm balloon diamters by 15 mm, 20 mm and 30 mm balloon lengths.
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