Atlas FDA

AMS 700™ Inflatable Penile Prosthesis (IPP

FDA premarket approval N970012/S201 · decided 2023-12-11

Approval details

PMA number
N970012
Supplement
S201
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
AMS 700™ Inflatable Penile Prosthesis (IPP
Generic name
Prosthesis, penis, inflatable
Applicant
Boston Scientific Corp
Date received
2023-11-15
Decision date
2023-12-11
Days to decision
26 days
Decision code
OK30
Product code
JCW
Advisory committee
Gastroenterology, Urology
Expedited review
No
Location
Marlboro, MA
Statement
a change to the process and equipment for mixing the silicone elastomer material used for extrusion of the kink resistant tubing (KRT) component of the AMS 700 IPP and AMS 800 AUS devices at Boston Scientific Corporation (BSC) St. Paul

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