SIMPSON-ROBERT FAMILY OF CORONARY DILATATION CATHETERS
FDA premarket approval P810046/S227 · decided 2008-12-10
Approval details
- PMA number
- P810046
- Supplement
- S227
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SIMPSON-ROBERT FAMILY OF CORONARY DILATATION CATHETERS
- Generic name
- STENT, CORONARY
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 2008-11-10
- Decision date
- 2008-12-10
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- MODIFICATION OF THE ENVIRONMENTAL MONITORING ACTION LIMITS FOR VIABLE AIR AND SURFACE TESTING IN THE MANUFACTURING PRODUCTION AREAS.
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