INCEPTA, ENERGEN, PUNCTUA, TELIGEN, VITALITY, DYNAGEN, INOGEN, ORIGEN ICDS
FDA premarket approval P960040/S319 · decided 2014-07-08
Approval details
- PMA number
- P960040
- Supplement
- S319
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INCEPTA, ENERGEN, PUNCTUA, TELIGEN, VITALITY, DYNAGEN, INOGEN, ORIGEN ICDS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2014-06-09
- Decision date
- 2014-07-08
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ADD A FUNCTIONALLY EQUIVALENT STERILIZATION CHAMBER; 2) ADD A THIRD ABATOR TO BE USED WITH THE ADDITIONAL STERILIZER; AND 3) INCLUDE STERILIZER CHAMBER ENHANCEMENTS REQUIRED FOR THE EXISTING AND ADDITIONAL STERILIZER CHAMBERS.
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