ADAPTER 2D MATRIX BARCODE VERIFICATION SYSTEM
FDA premarket approval P110001/S002 · decided 2011-12-19
Approval details
- PMA number
- P110001
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ADAPTER 2D MATRIX BARCODE VERIFICATION SYSTEM
- Generic name
- STENT, RENAL
- Applicant
- Abbott Vascular
- Date received
- 2011-11-21
- Decision date
- 2011-12-19
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NIN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- ADDITION OF AN AUTOMATED IN-PROCESS VERIFICATION SYSTEM.
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