NOVOSTE BETA - CATH SYSTEM
FDA premarket approval P000018/S041 · decided 2004-10-04
Approval details
- PMA number
- P000018
- Supplement
- S041
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NOVOSTE BETA - CATH SYSTEM
- Generic name
- Intravascular radiation delivery system
- Applicant
- Best Vascular, Inc.
- Date received
- 2004-06-28
- Decision date
- 2004-10-04
- Days to decision
- 98 days
- Decision code
- APPR
- Product code
- MOU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Norcross, GA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN NORCROSS, GEORGIA, TO PROCESS RADIATION SOURCE TRAINS FOR THE BETA-CATH SYSTEM.
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