PMA N970012S182
- Device
- AMS 700 Inflatable Penile Prosthesis (IPP) with InhibiZone Treatment
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S182
- Product code
- JCW
- Decision date
- 2020-09-16
- Generic name
- Prosthesis, penis, inflatable
- Approval order statement
- Add Sanofi in Brindisi, Italy as a supplier of Rifampin.
Current openFDA PMA Record#
- Device
- AMS 700 Inflatable Penile Prosthesis (IPP) with InhibiZone Treatment
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S182
- Product code
- JCW
- Generic name
- Prosthesis, penis, inflatable
- Decision date
- 2020-09-16
- Decision code
- OK30
- Date received
- 2020-08-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add Sanofi in Brindisi, Italy as a supplier of Rifampin.