PMA N970012S184
- Device
- 700 Inflatable Penile Prosthesis and AMS Ambicor Penile Prosthesis
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S184
- Product code
- JCW
- Decision date
- 2020-12-17
- Generic name
- Prosthesis, penis, inflatable
- Approval order statement
- Updates to the software for sterilization aeration at the BSC Coventry, Rhode Island facility.
Current openFDA PMA Record#
- Device
- 700 Inflatable Penile Prosthesis and AMS Ambicor Penile Prosthesis
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S184
- Product code
- JCW
- Generic name
- Prosthesis, penis, inflatable
- Decision date
- 2020-12-17
- Decision code
- OK30
- Date received
- 2020-12-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Updates to the software for sterilization aeration at the BSC Coventry, Rhode Island facility.