CROSSSAIL, OPENSAIL, RX CHASSIS I & III AND VOYAGER CORONARY DILATATION CATHETERS
FDA premarket approval P810046/S218 · decided 2005-01-14
Approval details
- PMA number
- P810046
- Supplement
- S218
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CROSSSAIL, OPENSAIL, RX CHASSIS I & III AND VOYAGER CORONARY DILATATION CATHETERS
- Generic name
- STENT, CORONARY
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 2004-12-21
- Decision date
- 2005-01-14
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- MANUFACTURING PROCESS CHANGE TO ALLOW STERILE PRODUCT RELEASE BASED ON DEMONSTRATION OF CONFORMITY TO PRE-DEFINED STERILIZATION PARAMETERS (PARAMETRIC RELEASE) RATHER THAN RELEASE BASED ON DEMONSTRATING NO GROWTH OF BIOLOGICAL INDICATORS (CONVENTIONAL RELEASE).
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