ACS RX ESPRIT
FDA premarket approval P810046/S177 · decided 1997-09-19
Approval details
- PMA number
- P810046
- Supplement
- S177
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACS RX ESPRIT
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 1997-04-21
- Decision date
- 1997-09-19
- Days to decision
- 151 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- Approval for the ACS RX ESPRIT(TM) Coronary Dilatation Catheter. THe device is indicated for: 1)balloon dilatation fo the stenotic portion of a coronary artery or bypass draft stenosis for the purpose of improving myocardial perfusion; and 2)balloon dilatation of a coronary artery occlusion ofr the purpose of restoring coronary flow in patients iwth S-T segment elevation myocardial infarction.
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