Model: PROV45
Catalog: A000973-4
DI: 10840143913549
Status: New
MRI: MR Conditional
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Description
LAA Exclusion System, PROV45
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
4f8ad8e3-4ea4-4b8e-8001-d255f95d72cf
Distribution Status:
In Commercial Distribution
DUNS Number:
006133784
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Pkg Type:
Box
Item #1 - Device ID:
30840143913543
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
1
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10840143913549
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10840143913549
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
Case
Item #3 - Device ID:
50840143913547
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
6
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
30840143913543
Item #3 - Device ID Issuing Agency:
GS1
Item #4 - Device ID:
10840143912122
Item #4 - Device ID Type:
Previous
Item #4 - Device ID Issuing Agency:
GS1
GMDN
Code: 35649
Name: Ligation clip, metallic
Definition:
A metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel, lymphatic vessel, other tubular anatomy or a tissue bundle, for permanent occlusion. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries; a dedicated, disposable clip applier may be included.
FDA Product Codes
PZX
Left Atrial Appendage Clip, Implantable
Premarket Submissions
Submission Number:
K233407
Supplement Number:
000
Device Sizes
Device Size - Size - @attributes - Unit:
Millimeter
Device Size - Size - @attributes - Value:
45
Device Size - Size Type:
Length
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Fahrenheit
Item #1 - Storage Handling Low - @attributes - Value:
-20
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Fahrenheit
Item #1 - Storage Handling High - @attributes - Value:
140
Item #1 - Storage Handling Type:
Handling Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling Low - @attributes - Value:
30
Item #2 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling High - @attributes - Value:
85
Item #2 - Storage Handling Type:
Handling Environment Humidity
Item #3 - Storage Handling Type:
Special Storage Condition, Specify
Item #3 - Storage Handling Special Condition Text:
Store in a cool, dry place