ENDOTAK LEAD ADAPTOR MODEL 6952
FDA premarket approval P910073/S072 · decided 2008-07-03
Approval details
- PMA number
- P910073
- Supplement
- S072
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENDOTAK LEAD ADAPTOR MODEL 6952
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2008-03-21
- Decision date
- 2008-07-03
- Days to decision
- 104 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR A MODIFICATION TO THE SPLIT TUBE WELD FOR ENDOTAK LEAD ADAPTOR MODEL 6952.
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