VENTAK P AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM/ LEAD TUNNELER KIT
FDA premarket approval P830060/S078 · decided 2014-03-31
Approval details
- PMA number
- P830060
- Supplement
- S078
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VENTAK P AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM/ LEAD TUNNELER KIT
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2014-03-04
- Decision date
- 2014-03-31
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL TO ADD STERILIZATION DETAIL INFORMATION AND TO REMOVE THE CIDEX CLEANING STEP FROM THE INSTRUCTIONS FOR USE.
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