PMA N970012S188
- Device
- AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S188
- Product code
- JCW
- Decision date
- 2021-07-08
- Generic name
- Prosthesis, penis, inflatable
- Approval order statement
- Addition of two sterilization chambers to conduct ethylene oxide gas sterilization Cycle 101.
Current openFDA PMA Record#
- Device
- AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S188
- Product code
- JCW
- Generic name
- Prosthesis, penis, inflatable
- Decision date
- 2021-07-08
- Decision code
- OK30
- Date received
- 2021-06-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of two sterilization chambers to conduct ethylene oxide gas sterilization Cycle 101.