MULTIPLE APPLICATION UTILITY MODEL 2909 (FROM V9.03 TO V9.04)
FDA premarket approval P910077/S155 · decided 2017-07-06
Approval details
- PMA number
- P910077
- Supplement
- S155
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MULTIPLE APPLICATION UTILITY MODEL 2909 (FROM V9.03 TO V9.04)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2016-10-19
- Decision date
- 2017-07-06
- Days to decision
- 260 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for the Automated Screening Tool software to aide in determining whether the S-ICD System is appropriate.
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