DEVICE: AMS 700 Accessory Kit (00878953001135)

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Device Record History
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Device Identifier (DI) Information
AMS 700 Accessory Kit
72401850
In Commercial Distribution

BOSTON SCIENTIFIC CORPORATION
00878953001135
GS1

1
021717889 *Terms of Use
Inflatable Penile Prosthesis with MS Pump Accessory Kit
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Device Characteristics
MR Conditional
No
No
Yes
Yes
No
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
36250 Inflatable penile prosthesis
An inflatable/deflatable sterile device designed of several interconnected components intended to be surgically implanted in a patient with erectile dysfunction (ED) [commonly known as impotence] in order to achieve selective penile tumescence and rigidity adequate for vaginal intercourse. It is available in a variety of designs and materials and typically consists of: 1) one or two inflatable cylinders implanted into the corpora cavernosa of the penis; 2) a subcutaneous manual pump bulb implanted into the scrotum; 3) a reservoir containing fluid (e.g., saline with/without radiopacifier) implanted in the abdomen; and 4) kink-resistant tubing that connect the component parts.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
JCW Prosthesis, Penis, Inflatable
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
N970012 000
N970012 083
N970012 113
N970012 118
N970012 128
N970012 131
N970012 145
N970012 150
N970012 157
N970012 158
N970012 177
N970012 196
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
00fe97d5-90f8-4092-9e08-d8e0efbd2810
March 24, 2025
9
September 24, 2014
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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