ACS RX SOLARIS CORONARY DILATATION CATHETER
FDA premarket approval P810046/S194 · decided 1999-04-14
Approval details
- PMA number
- P810046
- Supplement
- S194
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACS RX SOLARIS CORONARY DILATATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 1998-12-04
- Decision date
- 1999-04-14
- Days to decision
- 131 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- Approval for additional balloon sizes and an additional indication for use for the ACS RX Solaris(TM) Coronary Dilatation Catheter. The device as indicated for: a)balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. b) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction. c) Balloon dilatation of the ACS MULTI-L
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