PMA N970012S205
- Device
- AMS 700 Inflatable Penile Prosthesis with and without InhibiZone
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S205
- Product code
- JCW
- Decision date
- 2024-12-17
- Classification
- Gastroenterology, Urology
- Generic name
- Prosthesis, penis, inflatable
- Approval order statement
- changes to the TENACIO Pump drawings to improve manufacturability.
Current openFDA PMA Record#
- Device
- AMS 700 Inflatable Penile Prosthesis with and without InhibiZone
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S205
- Product code
- JCW
- Generic name
- Prosthesis, penis, inflatable
- Decision date
- 2024-12-17
- Decision code
- OK30
- Date received
- 2024-11-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes to the TENACIO Pump drawings to improve manufacturability.