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AMS 700™ Inflatable Penile Prosthesis (IPP) with and without lnhibiZone ™ Treatment

FDA premarket approval N970012/S192 · decided 2022-09-01

Approval details

PMA number
N970012
Supplement
S192
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
AMS 700™ Inflatable Penile Prosthesis (IPP) with and without lnhibiZone ™ Treatment
Generic name
Prosthesis, penis, inflatable
Applicant
Boston Scientific Corp
Date received
2022-08-19
Decision date
2022-09-01
Days to decision
13 days
Decision code
OK30
Product code
JCW
Advisory committee
Gastroenterology, Urology
Expedited review
No
Location
Marlboro, MA
Statement
Process change to the Global Labeling System version 3.0 software and infrastructure from the current Minnetonka Labeling System.

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510(k) clearances by this applicant

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