ACS TX 2000 VP CORONARY DILATATION CATHETER CAHTETERS
FDA premarket approval P810046/S182 · decided 1998-01-27
Approval details
- PMA number
- P810046
- Supplement
- S182
- Supplement type
- Normal 180 Day Track
- Trade name
- ACS TX 2000 VP CORONARY DILATATION CATHETER CAHTETERS
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 1997-11-24
- Decision date
- 1998-01-27
- Days to decision
- 64 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- Approval for an E-beam sterilization process validation protocol and a manufacturing site located at Guidant Corporation, Advanced Cardiovascular Systems, 26531 Ynez Rd., Temecula, CA 92591-4628.
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