PMA N970012S113
- Device
- AMS 700 AMBICOR INFLATABLE PENILE PROTHESIS
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S113
- Product code
- FHW
- Decision date
- 2015-10-14
- Classification
- Device, Impotence, Mechanical/hydraulic
- Generic name
- Device, impotence, mechanical/hydraulic
- Approval order statement
- APPROVAL FOR CHANGES IN QUALITY CONTROLS THAT ADD INSPECTION STEPS TO THE BLUNT NEEDLE ACCESSORY.
Current openFDA PMA Record#
- Device
- AMS 700 AMBICOR INFLATABLE PENILE PROTHESIS
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S113
- Product code
- FHW
- Generic name
- Device, impotence, mechanical/hydraulic
- Decision date
- 2015-10-14
- Decision code
- APPR
- Date received
- 2015-09-30
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR CHANGES IN QUALITY CONTROLS THAT ADD INSPECTION STEPS TO THE BLUNT NEEDLE ACCESSORY.