PUNCTUA, TELIGEN, ENERGEN AND INCEPTA ICDS
FDA premarket approval P960040/S292 · decided 2013-04-26
Approval details
- PMA number
- P960040
- Supplement
- S292
- Supplement type
- 30-Day Notice
- Trade name
- PUNCTUA, TELIGEN, ENERGEN AND INCEPTA ICDS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2013-04-01
- Decision date
- 2013-04-26
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- OPTIMIZATION OF WELD PROCESS PARAMETERS AND REMOVAL OF A WELD INSPECTION CRITERION FOR THE DEVICES.
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