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AMS 700 INFLATABLE PENILE PROSTHESIS

FDA premarket approval N970012/S103 · decided 2015-04-07

Approval details

PMA number
N970012
Supplement
S103
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
AMS 700 INFLATABLE PENILE PROSTHESIS
Generic name
Prosthesis, penis, inflatable
Applicant
Boston Scientific Corp
Date received
2015-01-09
Decision date
2015-04-07
Days to decision
88 days
Decision code
APPR
Product code
JCW
Advisory committee
Gastroenterology, Urology
Expedited review
No
Location
Marlboro, MA
Statement
APPROVAL FOR MODIFICATION OF AMS 800 INHIBIZONE (IZ) LABELING TO MATCH THE AMS 700 IZ LABELING; MODIFY TERMS FOR CLARITY AND ACCURACY, AND MODIFY THE LABELING TO CLARIFY THE UPPER QUANTITY OF IZ COATING ON THE DEVICE.

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510(k) clearances by this applicant

RecordFirmDate
IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) (K243245)Boston Scientific Corp2024-10-18
LUX-Dx II (M302); LUX-Dx II+ (M312) (K231328)Boston Scientific Corp2023-08-19
WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary (K152853)Boston Scientific Corp2015-11-20
AXIOS Stent with Electrocautery Enhanced Delivery System (K150692)Boston Scientific Corp2015-08-05
XXL Vascular Balloon Dilatation Catheter (K150303)Boston Scientific Corp2015-06-15
Chariot Guiding Sheath (K150186)Boston Scientific Corp2015-06-05
EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679)Boston Scientific Corp2015-05-29
JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820)Boston Scientific Corp2014-10-21