Accolade, Altrua 2, Essentio, Proponent
FDA premarket approval N970003/S227 · decided 2018-04-11
Approval details
- PMA number
- N970003
- Supplement
- S227
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Accolade, Altrua 2, Essentio, Proponent
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific Corp
- Date received
- 2018-03-13
- Decision date
- 2018-04-11
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Additional inspection criteria for pulse generator case halves with minor blemishes.
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|---|---|---|
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| 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 |
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