Accessory Kit
FDA premarket approval P940031/S078 · decided 2019-04-08
Approval details
- PMA number
- P940031
- Supplement
- S078
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Accessory Kit
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Boston Scientific
- Date received
- 2019-03-13
- Decision date
- 2019-04-08
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Modifications to the frequency, equipment and method for monitoring airborne particulates.
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