VENTAK PRX & VENTAK MINI ICD: LATTITUDE PATIENT MANAGMENT SYSTEM
FDA premarket approval P910077/S146 · decided 2014-09-05
Approval details
- PMA number
- P910077
- Supplement
- S146
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VENTAK PRX & VENTAK MINI ICD: LATTITUDE PATIENT MANAGMENT SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2014-08-15
- Decision date
- 2014-09-05
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- USE OF AN EXISTING SURFACE MOUNT TECHNOLOGY MANUFACTURING LINE AS AN ALTERNATE TO PRODUCE PRINTED CIRCUIT ASSEMBLIES.
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