ACS TX2000 VP CORONARY DILITATION CATHETER
FDA premarket approval P810046/S174 · decided 1997-06-11
Approval details
- PMA number
- P810046
- Supplement
- S174
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ACS TX2000 VP CORONARY DILITATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 1997-02-25
- Decision date
- 1997-06-11
- Days to decision
- 106 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR A MODIFICATION TO THELABELING OF THE ACS RX COMET(TM) CORONARY DILATATION CATHER AND ACS TX2000(TM) CORONARY DILATATION CATHETER.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.