PMA P980035S819
- Device
- Adapta, Versa, Sensia IPG (SED01); Adapta, Versa, Sensia IPG (ADSR01, VEDR01); Adapta, Versa, Sensia IPG (ADVDD01); Adap
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S819
- Product code
- NVZ
- Decision date
- 2025-07-29
- Classification
- Cardiovascular
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- an alternate lithium precut supplier
Current openFDA PMA Record#
- Device
- Adapta, Versa, Sensia IPG (SED01); Adapta, Versa, Sensia IPG (ADSR01, VEDR01); Adapta, Versa, Sensia IPG (ADVDD01); Adap
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S819
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2025-07-29
- Decision code
- OK30
- Date received
- 2025-07-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an alternate lithium precut supplier