AMERICAN MEDICAL SYSTEMS, INC.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Device, Incontinence, Mechanical/Hydraulic (EZY) (9) Prosthesis, Penis, Inflatable (JCW) (2) Device, Impotence, Mechanical/Hydraulic (FHW) (1)

Premarket Exempt

Yes No

Clear

Deactivation Package - 00878953000664 Catalog Number :

Device Description : 3 Tubing Plugs and 1 Straight Connector

Device Class : 3

Duns Number: 125111448

Premarket Exempt : No

Product Code : JCW, EZY

Prescription Use : Yes

Device Count : 1

AMS 800 Artificial Urinary Sphincter - 00878953000688 Catalog Number :

Device Description : Control Pump

Device Class : 3

Duns Number: 125111448

Premarket Exempt : No

Product Code : EZY

Prescription Use : Yes

Device Count : 1

Closing Tool - 00878953000701 Catalog Number :

Device Description : Closing Tool

Device Class :

Duns Number: 125111448

Premarket Exempt : No

Product Code : JCW, FHW

Prescription Use : Yes

Device Count : 1

AMS 800 Artificial Urinary Sphincter - 00878953000718 Catalog Number :

Device Description : Occlusive Cuff

Device Class : 3

Duns Number: 125111448

Premarket Exempt : No

Product Code : EZY

Prescription Use : Yes

Device Count : 1

AMS 800 Artificial Urinary Sphincter - 00878953000725 Catalog Number :

Device Description : Occlusive Cuff

Device Class : 3

Duns Number: 125111448

Premarket Exempt : No

Product Code : EZY

Prescription Use : Yes

Device Count : 1

AMS 800 Artificial Urinary Sphincter - 00878953000732 Catalog Number :

Device Description : Occlusive Cuff

Device Class : 3

Duns Number: 125111448

Premarket Exempt : No

Product Code : EZY

Prescription Use : Yes

Device Count : 1

AMS 800 Artificial Urinary Sphincter - 00878953000749 Catalog Number :

Device Description : Occlusive Cuff

Device Class : 3

Duns Number: 125111448

Premarket Exempt : No

Product Code : EZY

Prescription Use : Yes

Device Count : 1

AMS 800 Artificial Urinary Sphincter - 00878953000756 Catalog Number :

Device Description : Occlusive Cuff

Device Class : 3

Duns Number: 125111448

Premarket Exempt : No

Product Code : EZY

Prescription Use : Yes

Device Count : 1

AMS 800 Artificial Urinary Sphincter - 00878953000763 Catalog Number :

Device Description : Occlusive Cuff

Device Class : 3

Duns Number: 125111448

Premarket Exempt : No

Product Code : EZY

Prescription Use : Yes

Device Count : 1

AMS 800 Artificial Urinary Sphincter - 00878953000770 Catalog Number :

Device Description : Occlusive Cuff

Device Class : 3

Duns Number: 125111448

Premarket Exempt : No

Product Code : EZY

Prescription Use : Yes

Device Count : 1

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