ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE PACEMAKERS
FDA premarket approval N970003/S182 · decided 2015-11-03
Approval details
- PMA number
- N970003
- Supplement
- S182
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE PACEMAKERS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific Corp
- Date received
- 2015-08-21
- Decision date
- 2015-11-03
- Days to decision
- 74 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR DESIGN CHANGES TO THE ACCELEROMETER COMPONENT AND ASSOCIATED CHANGES.
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