INCEPTA, ENERGEN,PUNCTUA, DYNAGEN, INOGEN, ORIGEN ICD'S
FDA premarket approval P960040/S352 · decided 2015-08-08
Approval details
- PMA number
- P960040
- Supplement
- S352
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INCEPTA, ENERGEN,PUNCTUA, DYNAGEN, INOGEN, ORIGEN ICD'S
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2015-07-13
- Decision date
- 2015-08-08
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ADD AN ADDITIONAL INSPECTION STEP TO PULSE GENERATOR CASE HALF MANUFACTURING, ALONG WITH ASSOCIATED SPECIFICATION AND INSPECTION CRITERIA, THAT WILL ALLOW PULSE GENERATOR CASE HALF DISCONTINUITIES TO BE DISTINGUISHED FROM DENTS.
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