Collection: Fast Track Requests
FDA documents available for fast-track requests typically delivered within 1 to 2 weeks. Our fast-track request service identifies previously requested and redacted documents for quick access.
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FDA Device Info: Guidance for Industry and FDA Staff Intravascular Administration Sets
Regular price $149.00 USDRegular priceUnit price / per -
FDA Device Info: Letters sent by FDA to manufacturers of Automated External Defibrillators (AEDs)
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FDA Device Info: PMA-related annual reports submitted by Atricure, Inc.
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FDA Device Info: PASs submitted by Atricure, Inc.
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FDA Device Info: Master File MAF-2032/A008
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FDA Device Info: Deidentified original patient data from the CARTIVA MOTION trial
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FDA Device Info: Annual Reports for PMAs 2/10/2014
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FDA PMA Number P020014, ESSURE SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA PMA Number P900032, EXCIMER LASER MODEL DYMER (R) 200+
Regular price $149.00 USDRegular priceUnit price / per -
FDA PMA Number P810046, SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE
Regular price $149.00 USDRegular priceUnit price / per -
FDA PMA Number P900033, INTEGRA DERMAL REGENERATION TEMPLATE
Regular price $149.00 USDRegular priceUnit price / per -
FDA PMA Number P010030, WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST
Regular price $149.00 USDRegular priceUnit price / per -
FDA PMA Number P120005, DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA PMA Number P840002, STAT-PACE II
Regular price $149.00 USDRegular priceUnit price / per -
FDA PMA Number P040003, EXABLATE
Regular price $149.00 USDRegular priceUnit price / per -
FDA PMA Number P020002, THINPREP (R) IMAGING SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA PMA Number P030036, SelectSecure MRI SureScan Lead
Regular price $149.00 USDRegular priceUnit price / per -
FDA PMA Number P860004, SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA SSED for PMA Number P910071, ADATOMED SILICONE OIL OP5000
Regular price $149.00 USDRegular priceUnit price / per -
FDA PMA Number P950008, SILIKON 1000
Regular price $149.00 USDRegular priceUnit price / per -
FDA PMA Number P130008, INSPIRE II UPPER AIRWAY STIMULATOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA PMA Number P030053, MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS
Regular price $149.00 USDRegular priceUnit price / per -
FDA PMA Number P870024, FLUOROPERM RGP CONTACT LENSES
Regular price $149.00 USDRegular priceUnit price / per -
FDA PMA Number P030054, QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUADRA FAMILY OF CRT-DS
Regular price $149.00 USDRegular priceUnit price / per -
FDA PMA Number P860003, UVAR PHOTOPHERESIS SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA PMA Number P170012, HEMOBLAST™ Bellows Laparoscopic Applicator
Regular price $149.00 USDRegular priceUnit price / per -
FDA PMA Number P990004, SURGIFORM ABSORBABLE GELATION SPONGE, USP
Regular price $149.00 USDRegular priceUnit price / per -
FDA PMA Number P860057, EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES
Regular price $149.00 USDRegular priceUnit price / per -
FDA PMA Number P100005, M-VU ALGORITHM ENGINE
Regular price $149.00 USDRegular priceUnit price / per -
FDA PMA Number P150004, Axium Neurostimulator System
Regular price $149.00 USDRegular priceUnit price / per -
FDA PMA Number P050027, KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA PMA Number P080003, Selenia Dimensions/3Dimensions 3D System
Regular price $149.00 USDRegular priceUnit price / per -
FDA PMA Number P140023, COBAS KRAS MUTATION TEST
Regular price $149.00 USDRegular priceUnit price / per -
FDA PMA Number P090016, BELOTERO BALANCE
Regular price $149.00 USDRegular priceUnit price / per -
FDA PMA Number P120022, Therascreen EGFR RGQ PCR Kit
Regular price $149.00 USDRegular priceUnit price / per -
FDA PMA Number P950020, WOLVERINE CORONARY CUTTING BALLOON (MONORAIL & OVER-THE-WIRE)
Regular price $149.00 USDRegular priceUnit price / per