VENTAK P2 PACEMAKER
FDA premarket approval P930035/S027 · decided 2014-07-30
Approval details
- PMA number
- P930035
- Supplement
- S027
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VENTAK P2 PACEMAKER
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2014-06-30
- Decision date
- 2014-07-30
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CHANGE IN THE BIOBURDEN SAMPLING FREQUENCY IN THE CLONMEL AND ST PAUL FACILITIES FOR THE DEVICES.
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