ABBOTT IMX SA
FDA premarket approval P910077/S016 · decided 1996-11-18
Approval details
- PMA number
- P910077
- Supplement
- S016
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ABBOTT IMX SA
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1996-07-09
- Decision date
- 1996-11-18
- Days to decision
- 132 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR MODEL 2840, SOFTWARE APPLICATION, VERSION 2.2 WHICH IS A MODIFICATION OF VERSION 2.1
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