PMA N970012S111
- Device
- AMS 700 INFLATABLE PENILE PROSTHESIS
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S111
- Product code
- FHW
- Decision date
- 2016-02-03
- Classification
- Device, Impotence, Mechanical/hydraulic
- Generic name
- Device, impotence, mechanical/hydraulic
- Approval order statement
- Approval for a change in supplier for poly(ethylene terephthalate) (PET) yarn resin and supplier.
Current openFDA PMA Record#
- Device
- AMS 700 INFLATABLE PENILE PROSTHESIS
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S111
- Product code
- FHW
- Generic name
- Device, impotence, mechanical/hydraulic
- Decision date
- 2016-02-03
- Decision code
- APPR
- Date received
- 2015-09-18
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change in supplier for poly(ethylene terephthalate) (PET) yarn resin and supplier.