PMA N970012S206

Device: AMS 700 Inflatable Penile Prosthesis with and without InhibiZone
Applicant: Boston Scientific Corp
PMA number: N970012
Supplement: S206
Product code: JCW
Decision date: 2025-03-18
Classification: Gastroenterology, Urology
Generic name: Prosthesis, penis, inflatable
Approval order statement: Approval for changes to the packaging artwork and labels, Instructions for Use, eIFU Insert, and Patient Guide. These changes include the addition of symbols and minor revisions to the text for clarity, consistency, and readability. There are no substantive changes to the indications for use, contraindications, warnings, or operational instructions.

Current openFDA PMA Record#

Device: AMS 700 Inflatable Penile Prosthesis with and without InhibiZone
Applicant: Boston Scientific Corp
PMA number: N970012
Supplement: S206
Product code: JCW
Generic name: Prosthesis, penis, inflatable
Decision date: 2025-03-18
Decision code: APPR
Date received: 2025-01-30
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for changes to the packaging artwork and labels, Instructions for Use, eIFU Insert, and Patient Guide. These changes include the addition of symbols and minor revisions to the text for clarity, consistency, and readability. There are no substantive changes to the indications for use, contraindications, warnings, or operational instructions.