PMA N970012S112
- Device
- AMS 700 INFLATABLE PENILE PROSTHESIS
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S112
- Product code
- FHW
- Decision date
- 2015-10-30
- Classification
- Device, Impotence, Mechanical/hydraulic
- Generic name
- Device, impotence, mechanical/hydraulic
- Approval order statement
- CHANGES IN THE FABRIC WASH PROCESS WATER LEVEL RANGE, THE RINSE CYCLE PH TESTING, AND THE INSPECTION OF CUT FABRIC ANGLE MEASUREMENT.
Current openFDA PMA Record#
- Device
- AMS 700 INFLATABLE PENILE PROSTHESIS
- Applicant
- Boston Scientific Corp
- PMA number
- N970012
- Supplement
- S112
- Product code
- FHW
- Generic name
- Device, impotence, mechanical/hydraulic
- Decision date
- 2015-10-30
- Decision code
- OK30
- Date received
- 2015-09-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES IN THE FABRIC WASH PROCESS WATER LEVEL RANGE, THE RINSE CYCLE PH TESTING, AND THE INSPECTION OF CUT FABRIC ANGLE MEASUREMENT.