ENTOTAK LEAD SYSTEM
FDA premarket approval P910073/S120 · decided 2013-09-17
Approval details
- PMA number
- P910073
- Supplement
- S120
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ENTOTAK LEAD SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2013-08-19
- Decision date
- 2013-09-17
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ADD A NEW PRIMARY SUPPLIER OF THE SERIAL NUMBER LABELS FOR THE DEFIBRILLATION LEADS AND CORONARY SINUS LEADS FOR THE DEVICES.
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