AMS 700 INFLATABLE PENILE PROSTHESIS
FDA premarket approval N970012/S083 · decided 2012-05-07
Approval details
- PMA number
- N970012
- Supplement
- S083
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AMS 700 INFLATABLE PENILE PROSTHESIS
- Generic name
- Prosthesis, penis, inflatable
- Applicant
- Boston Scientific Corp
- Date received
- 2010-11-17
- Decision date
- 2012-05-07
- Days to decision
- 537 days
- Decision code
- APPR
- Product code
- JCW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- APPROVAL FOR CHANGES IN THE MATERIAL FORMULATION AND SPECIFICATIONS OF THE SUTURE-TIE CONNECTORS.
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