AMS 700 Inflatable Penile Prosthesis with and without InhibiZone
FDA premarket approval N970012/S206 · decided 2025-03-18
Approval details
- PMA number
- N970012
- Supplement
- S206
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- AMS 700 Inflatable Penile Prosthesis with and without InhibiZone
- Generic name
- Prosthesis, penis, inflatable
- Applicant
- Boston Scientific Corp
- Date received
- 2025-01-30
- Decision date
- 2025-03-18
- Days to decision
- 47 days
- Decision code
- APPR
- Product code
- JCW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- Approval for changes to the packaging artwork and labels, Instructions for Use, eIFU Insert, and Patient Guide. These changes include the addition of symbols and minor revisions to the text for clarity, consistency, and readability. There are no substantive changes to the indications for use, contraindications, warnings, or operational instructions.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) (K243245) | Boston Scientific Corp | 2024-10-18 |
| LUX-Dx II (M302); LUX-Dx II+ (M312) (K231328) | Boston Scientific Corp | 2023-08-19 |
| WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary (K152853) | Boston Scientific Corp | 2015-11-20 |
| AXIOS Stent with Electrocautery Enhanced Delivery System (K150692) | Boston Scientific Corp | 2015-08-05 |
| XXL Vascular Balloon Dilatation Catheter (K150303) | Boston Scientific Corp | 2015-06-15 |
| Chariot Guiding Sheath (K150186) | Boston Scientific Corp | 2015-06-05 |
| EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679) | Boston Scientific Corp | 2015-05-29 |
| JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820) | Boston Scientific Corp | 2014-10-21 |