SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETERS VOYAGER/VOYAGER NC
FDA premarket approval P810046/S236 · decided 2010-04-23
Approval details
- PMA number
- P810046
- Supplement
- S236
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETERS VOYAGER/VOYAGER NC
- Generic name
- STENT, CORONARY
- Applicant
- Advanced Cardiovascular Systems, Inc.
- Date received
- 2010-03-23
- Decision date
- 2010-04-23
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- REQUESTED A CHANGE IN MANUFACTURING EQUIPMENT USED TO COAT THE STENT DELIVERY SYSTEM AND BALLOON DILATATION CATHETERS.
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