ACS RX LIFESTREAM
FDA premarket approval P810046/S175 · decided 1997-07-03
Approval details
- PMA number
- P810046
- Supplement
- S175
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ACS RX LIFESTREAM
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 1997-03-05
- Decision date
- 1997-07-03
- Days to decision
- 120 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR AN ALTERNATE METHOD OF STERILIZATION FOR THE ACS RX LIFESTREAM(TM) CORONARY DILATATION CATHETER.
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