ACS SIMPSON-ROBERT CORONARY DILATATION CATHETER
FDA premarket approval P810046/S157 · decided 1995-12-05
Approval details
- PMA number
- P810046
- Supplement
- S157
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ACS SIMPSON-ROBERT CORONARY DILATATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 1995-09-14
- Decision date
- 1995-12-05
- Days to decision
- 82 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR THE ACS OTW LIFESTREAM CORONARY DILATATION CATHETER
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