BOSTON SCIENTIFIC CORPORATION

Address:Two Scimed Place,Maple Grove,MN,55311,US

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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

Bronchoscope (flexible or rigid) (EOQ) (8) mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator (OTN) (2)

Premarket Exempt

No Yes

Clear

Advantage Fit Ultra System - 00191506007669 Catalog Number : M0068502160

Device Description : Transvaginal Mid-Urethral Sling

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : OTN

Prescription Use : Yes

Device Count : 1

Lynx Ultra System - 00191506007676 Catalog Number : M0068503060

Device Description : Suprapubic Mid-Urethral Sling

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : OTN

Prescription Use : Yes

Device Count : 1

EXALT™ - 00191506007805 Catalog Number : M00542760

Device Description : Monitor

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

EXALT™ - 00191506007812 Catalog Number : M0054276H0

Device Description : Monitor

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

EXALT™ - 00191506007836 Catalog Number : M0054276R0

Device Description : Monitor

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

EXALT™ - 00191506007843 Catalog Number : M0054276Z0

Device Description : Monitor

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Exalt ™ - 00191506007850 Catalog Number : M00542770

Device Description : Monitor

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Exalt ™ - 00191506007867 Catalog Number : M0054277H0

Device Description : Monitor

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Exalt ™ - 00191506007881 Catalog Number : M0054277R0

Device Description : Monitor

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

Exalt ™ - 00191506007898 Catalog Number : M0054277Z0

Device Description : Monitor

Device Class : 2

Duns Number: 021717889

Premarket Exempt : No

Product Code : EOQ

Prescription Use : Yes

Device Count : 1

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