FDA.report

Pacific™ Plus

Primary DI
08033477072531
Brand
Pacific™ Plus
Company
MEDTRONIC, INC.
Model
PCP040100200
Device description
CATH PCP040100200 PLUS US D4L100UL2000
Published
2023-11-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
LITCatheter, angioplasty, peripheral, transluminal

Product Code Classifications

CodeDeviceSpecialtyClass
LITCatheter, Angioplasty, Peripheral, TransluminalCardiovascular2

Premarket Submissions

SubmissionSupplement
K202800000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K202800000Pacific Plus PTA CatheterMedtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC)2020-11-18LIT

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08033477072531PrimaryGS10

GMDN Terms

TermDefinition
Peripheral angioplasty balloon catheter, basicA sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.

Device Sizes

TypeValueUnit
Length100Millimeter
Outer Diameter4Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store at controlled room temperature, in a dry place. Keep away from sunlight. Do not expose to organic solvents (such as alcohol), ionizing radiation, or ultraviolet light.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags

DUNS number
006261481
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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