Atlas FDA

AMBICOR INFLATABLE PENILE PROSTHESES

FDA premarket approval N970012/S121 · decided 2017-02-10

Approval details

PMA number
N970012
Supplement
S121
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
AMBICOR INFLATABLE PENILE PROSTHESES
Generic name
Prosthesis, penis, inflatable
Applicant
Boston Scientific Corp
Date received
2016-11-09
Decision date
2017-02-10
Days to decision
93 days
Decision code
APPR
Product code
JCW
Advisory committee
Gastroenterology, Urology
Expedited review
No
Location
Marlboro, MA
Statement
Approval for minor changes to dimensions and tolerances on the Ambicor device engineering drawings as part of ongoing remediation activities to align the engineering drawings with historical design intent and current manufacturing.

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