Endotak Lead System
FDA premarket approval P910073/S159 · decided 2021-01-13
Approval details
- PMA number
- P910073
- Supplement
- S159
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Endotak Lead System
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2021-01-11
- Decision date
- 2021-01-13
- Days to decision
- 2 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Add a new supplier of nitrile gloves, Ansell.
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