Implantable Cardioverter Defibrillator (ICD)
FDA premarket approval P960040/S443 · decided 2019-10-29
Approval details
- PMA number
- P960040
- Supplement
- S443
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Implantable Cardioverter Defibrillator (ICD)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2019-10-21
- Decision date
- 2019-10-29
- Days to decision
- 8 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Revert to previously approved controlled environment area specifications for feedthrough component and sputter coating manufacturing lines, eliminate use of booties, and change the hand sanitization method.
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